Patients must not have a history of immune-mediated pneumonitis or colitis that required interruption of therapy or treatment of steroids
Patients with active colitis or immune-mediated colitis that has not resolved to grade 1 or less.
Subjects who experienced immune related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immuno-oncology agents
Treatment-related, immune-mediated adverse events associated with prior immunotherapeutic agents
Prior history of hypersensitivity, drug or radiation-induced, or other immune-mediated pneumonitis
Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis, (non-infectious) pneumonitis.
Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
History of CTCAE >= grade 2 immune mediated endocrinopathy from prior cancer immunotherapy
Requirement for systemic immune suppressive medication
A life-threatening (Grade 4) immune-mediated adverse event related to prior immunotherapy.
Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.
Evidence of other immune related disease /conditions.
Must not have experienced a Grade ?3 immune-related AE or an immune-related neurologic or ocular AE, pneumonitis or cardiomyopathy of any grade while receiving prior immunotherapy.
Patients with prior ? Grade 3, serious, or life threatening immune-mediated reactions following prior anti-PD-1 or other immune-oncology therapies
Participants undergoing active therapy for immune-mediated or infectious colitis upon admission for allogeneic HSCT
Treatment with systemic immune modulators 2 weeks before enrollment (day 1)
Prior immune therapy (e.g. related vaccinia and fowlpox vaccines or antigen-specific peptides) is allowed
Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)
History of any of the following toxicities associated with a prior immunotherapy: \r\n* Grade > 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy\r\n* Immune mediated adverse event that was considered related to previous immunotherapy and is still > grade 1 with immune suppressive therapy
Prior exposure to immune-mediated therapy
History of immune-mediated pneumonitis
History of auto-immune disease (e.g., thyroiditis, lupus), except vitiligo
No active auto-immune disease and not on therapy for auto-immune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligible
Use of immune suppressive agents within 30 days
History of grade 3 or higher immune-mediated adverse event (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune-modulatory therapy (e.g., checkpoint inhibitors, costimulatory agents etc.) or any grade immune-related adverse events (AEs) that required immune suppressive therapy
Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of REGN2810, or associated with immune-mediated adverse events that were ? grade 1 within 90 days prior to the first dose of REGN2810, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)
IMMUNE RECONSTITUTION STUDY ONLY: Be willing and able to provide written consent/assent for the immune reconstitution portion of the trial only
Has evidence of immune- mediated hepatitis, nephritis, or thyroiditis
Patients that had grade 3/4 immune-related adverse events (AEs) on ipilimumab that required more than 12 weeks of immune suppression with corticosteroids
Patients with history of alcoholic or non-alcoholic steatohepatitis (NASH), auto-immune hepatitis, or previous grade 3-4 drug-related hepatitis
Must not have experienced a Grade ?3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy.
The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of:\r\n* Vitiligo
Concurrent use of systemic immune suppressive other than calcineurin inhibitors and sirolimus
Significant auto-immune disease requiring hospitalization within the past two years or any history of life-threatening auto-immune disease
History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
Prior treatment with immune-modulating agents within 28 days before REGN2810
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
Prior auto-immune disease
Patients must not have a history of any immune system disorder, or laboratory abnormality or any condition that could potentially alter immune function
Current use of illicit drugs, glucocorticoids other than those necessary for concurrent radiotherapy, adrenal failure or septic shock, or other immune-suppressing or immune-modulating drugs. Glucocorticoids for anti-emetic prophylaxis and therapy should only be used as a last resort.
Evidence of other immune related disease/conditions.
History of or current immunodeficiency disease or prior treatment compromising immune function
Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions)
History of auto-immune disease per physician discretion
The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: vitiligo, diabetes or thyroid dysfunction
Patients with active auto-immune disease requiring immunosuppressive medication
For melanoma patients, patients must have received prior programmed cell death protein 1 (PD-1) therapy and have progressed immune-related progressive disease (irPD) by immune-related Response Criteria (irRC)
Patients may not be receiving any steroids or other anti-immune therapy at the time of registration
Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of REGN2810. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immune suppression.
Patients with active neurological auto immune or inflammatory disorders(e.g. Guillain Barre Syndrome, Amyptrophic Lateral Sclerosis)
Prior immune-oncology therapy
Prior treatment with an immune-therapy.
Any immunodeficiency disease or immune-compromised state
Use of immune modulators and/or any immunosuppressive drugs.
History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
No prior exposure to immune-mediated therapy,
History of auto-immune disease
Patients with known auto-immune disease
Subject who has active auto-immune disease.
Active auto-immune disease
Any congenital or acquired condition leading to compromised ability to generate an immune response
Requirement for continual immune suppression
A history of any grade immune-related ocular event.
Previously received an immune therapy that was discontinued due to immune-related AEs, regardless of grade.
Prior exposure to immune-mediated therapy
New systemic immune suppressive agent added for the treatment of chronic GVHD within 2 weeks prior to enrollment\r\n* Addition of a new systemic immune suppressive treatment simultaneously with ixazomib is also prohibited
No prior exposure to immune-mediated therapy;
No prior exposure to immune-mediated therapy
Willingness to provide blood samples for immune assessment and other tests
History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy
Prior exposure to selected immune cell-modulating antibody regimens
Prior therapy with any antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
Systemic immune suppression or systemic therapy for cGvHD started within preceding 4 weeks including extracorporeal photopheresis
Auto-immune disease
Subjects with relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
Evidence of immunodeficiency or immune suppression
Active joint inflammation or other immune disorder involving joints (osteoarthritis is not exclusionary)
Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
Treatment with immune modulators including
Previous immune-mediated therapy
normal immune function
Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
Immune suppression
Active known auto-immune disease with the exception of autoimmune thyroiditis, vitiligo, and alopecia;
Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;
Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.
Prior treatment with systemic immune modulating agents (other than anti-PD-1/PD-L1 agents) that was within 28 days prior to enrollment, or within 90 days prior to enrollment if there was an immune related adverse event, or associated with toxicity that resulted in discontinuation of the immune modulating agent
f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
Patients with history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active auto-immune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with rhIL7 therapy
Prior therapy with agents targeting immune coinhibitory receptors.
immunodeficiency, immune compromised state or receiving immunosuppressive therapy
History of immune-mediated pneumonitis
Subject has history of chronic or recurrent (within the last year prior to screening) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
Systemic immune suppression or systemic therapy for cGVHD started within preceding 4 weeks
If participating in optional biospecimen collection; as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; type I diabetes; acute hepatitis; recent vaccination for viral disease)
Immune suppressive medication
Immune compromised or other serious medical conditions, other than cancer diagnostic, at enrollment; immune compromised subjects will be defined as having absolute neutrophil count (ANC) less than 1000 as determined by complete blood count testing (CBD) performed weekly as standard of care in individuals receiving chemoradiation
Other uncontrolled immune-compromising illness
Co-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroids
Subject has significant auto-immune disease
Significant auto-immune disease requiring hospitalization within the past two years or any history of life-threatening auto-immune disease
History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
Patient has compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
Auto-immune disease, which:
History of autoimmune disease
People with autoimmune disease
Patients must not have any known autoimmune disease
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-4) therapy that has been completely resolved for more than 4 weeks prior to C1D1.
History of autoimmune disease
Has an active or inactive autoimmune process
History of autoimmune disease
History of autoimmune disease
Active or history of autoimmune disease or immune deficiency;
Active or history of autoimmune disease or immune deficiency
Participant must not have an active or prior documented autoimmune disease in the last 2 years.
Active autoimmune disease
Active autoimmune disease
History of autoimmune disease
History of autoimmune disease
History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other systemic autoimmune disease.
History of symptomatic autoimmune disease
Active autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditis
Active autoimmune disease
Any active or inactive autoimmune disease or syndrome
Active autoimmune disease or a history of severe autoimmune disease or syndrome
History of, active or suspicion of autoimmune disease
History of autoimmune disease
Active or history of autoimmune disease or immune deficiency
History or risk of autoimmune disease
Active or history of autoimmune disease or immune deficiency
Active autoimmune disease or a documented history of autoimmune disease.
Active or known autoimmune disease
History of autoimmune disease
History of autoimmune disease
Patients with any active autoimmune disease
Patients with autoimmune disease
History of major organ autoimmune disease
Active or history of autoimmune disease or immune deficiency;
History of autoimmune disease
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded
Active or history of autoimmune disease or immune deficiency
Active or prior documented autoimmune or inflammatory disease with some exceptions
History of or current active autoimmune diseases
Patients/subjects with autoimmune disease
History of autoimmune disease
Active or history of autoimmune disease or immune deficiency
Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
Active autoimmune disease or a history of severe autoimmune disease or syndrome
Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
History of major organ autoimmune disease.
Has a history of clinically severe autoimmune disease, or history of organ transplant
Patients with history of or active autoimmune disease including thyroiditis, colitis, nephritis, neuropathy or pneumonitis
History of severe autoimmune disease
Participants with chronic autoimmune disease
clinical history, prior diagnosis, or overt evidence of autoimmune disease
Active or history of medically significant autoimmune disease
History of autoimmune disease
FOR ALL PHASES (Ib AND II): History of, or current autoimmune disease
Patients with chronic autoimmune disease
Patients with active known autoimmune disease are ineligible
Patients who are on treatment for rheumatological or autoimmune disease unless approved by the Investigator in consultation with the Sponsor (e.g., as for replacement therapy for autoimmune thyroiditis or diabetes).
Active uncontrolled autoimmune cytopenias
Active or chronic autoimmune diseases
Patients/subjects with autoimmune disease
Has an active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism, interstitial lung disease, colitis
History of major organ autoimmune disease
Those with active autoimmune disease are excluded from the study
Active autoimmune disease.
History of major organ autoimmune disease
History of autoimmune disease(s)
Ongoing or recent significant autoimmune disease
Autoimmune disease
History of active autoimmune disease
Must not have active autoimmune disease (see protocol for exceptions)
History of chronic inflammatory or autoimmune disease
Active autoimmune disease requiring systemic therapy. Patients with a history of autoimmune disease must be counselled regarding the unknown potential of exacerbating or reactivating previous or dormant autoimmunity during the consent process.
Known autoimmune disease
History of prior or current autoimmune disease
Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; however, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled
History of autoimmune disease, except for vitiligo, diabetes, and autoimmune thyroiditis
Patients with active autoimmune disease or history of transplantation; patients with indolent or chronic autoimmune disease not requiring steroid treatment are considered eligible
DONOR: History of autoimmune disease
No current or prior autoimmune disease with the exception of vitiligo and autoimmune alopecia (Arm B only)
Active or inactive autoimmune process.
Active autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:
Active autoimmune or auto-inflammatory ocular disease within 6 months
Patients with an active autoimmune disease
History of autoimmune disease as detailed above
Patients with active or documented history of autoimmune disease;
Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
Active autoimmune disease or documented history of autoimmune disease.
Any active autoimmune disease
Active autoimmune disease or a documented history of autoimmune disease.
Active autoimmune disease
Must not have been diagnosed with autoimmune disease or be immunosuppressed
Active autoimmune disease prior to transplant
Have history of uncontrolled autoimmune disease.
History of autoimmune disease
History of major organ autoimmune disease
Has active autoimmune disease or history of transplantation
Active or history of autoimmune disease or immune deficiency
History of, or current autoimmune disease
Patients with autoimmune disease requiring systemic corticosteroid treatment (and previously ineligible to receive systemic immunotherapies for melanoma) are allowed on condition that they do not receive more than 20 mg of daily dose methylprednisolone, prednisone, or its equivalent; this does not include autoimmune diseases caused by previous immunotherapy treatments for melanoma that require ongoing treatment with corticosteroids (e.g. autoimmune colitis or autoimmune hepatitis receiving corticosteroids)
Patients with a history of autoimmune disease requiring continuous treatment
Subjects with a history of known autoimmune disease are excluded from this study
Autoimmune disease
Patients with a history of autoimmune disease will also be excluded, specifically those with any active autoimmune disease or a condition that requires systemic corticosteroids; exceptions to this are subjects with vitiligo and type I diabetes mellitus, who will be permitted to enroll
Patients should have no evidence of being immunocompromised as listed below:\r\n* Human immunodeficiency virus positivity\r\n* Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; patients with endocrine disease that is controlled by replacement therapy including thyroid disease and adrenal disease and vitiligo may be enrolled\r\n* History of splenectomy
Active autoimmune diseases requiring treatment or a recent history of autoimmune disease requiring therapy, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis; however, patients with vitiligo may be enrolled; (patients with history of autoimmune thyroid conditions will be allowed as these patients will be on replacement medications)
Known autoimmune disease or presence of autoimmune phenomena
Subjects with any active autoimmune disease or a history of known autoimmune disease
Active autoimmune disease
Active autoimmune disease or a documented history of autoimmune disease
Subjects with any active or inactive autoimmune process
Subjects with any active or inactive autoimmune process
Has an active autoimmune disease.
Active or chronic autoimmune diseases
History of autoimmune disease.
History of autoimmune disease
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions
Active or history of autoimmune disease or immune deficiency
Active autoimmune disease.
Active or inactive autoimmune disease or syndrome.
Subjects who have known active autoimmune disease or a history of autoimmune disease which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids;
History of autoimmune disease
Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
Active or prior documented autoimmune disease within the last 2 years.
History of autoimmune disease
History of autoimmune disease
History of autoimmune disease
Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
History of autoimmune disease
Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other central nervous system (CNS) autoimmune disease.
Patients with active autoimmune disease. (Patients with endocrine autoimmune diseases requiring replacement therapy alone are allowed.)
History of autoimmune disease
Has active autoimmune disease.
Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
History of autoimmune disease
Active autoimmune disease
Subjects who have any active or inactive autoimmune disease or syndrome.
Patients with active autoimmune disease
History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
History of autoimmune disease
Active or prior autoimmune disease or history of immunodeficiency.
History of autoimmune disease
Active or prior autoimmune disease or history of immunodeficiency
History of autoimmune disease
History of autoimmune disease
Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.
Active or history of autoimmune disease or immune deficiency
Clinically active autoimmune disease.
Previous clinical evidence of an autoimmune disease
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte antigen 4 [CTLA-4]) therapy that has been completely resolved for more than 4 weeks
Active or history of autoimmune disease
Any active or history of a known autoimmune disease
Active autoimmune disease
Has a history of clinically severe autoimmune disease, or history of organ transplant
Patients with uncontrolled autoimmune diseases.
Has an active or inactive autoimmune process.
Active autoimmune disease or a documented history of autoimmune disease.
Active autoimmune disease, history of autoimmune disease
Active autoimmune disease or history of known autoimmune disease
Active autoimmune disease or documented history of autoimmune disease.
Active autoimmune disease or a documented history of autoimmune disease.
Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study
History of autoimmune diseases
Active or inactive autoimmune process.
Active autoimmune disease
Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions.
History of autoimmune diseases
Patient with an autoimmune condition
Patients with active autoimmune disease or history of transplantation
History of autoimmune disease
Active autoimmune diseases requiring treatment or a history of autoimmune disease.
Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; however, patients with vitiligo or clinically stable autoimmune endocrine disease who are on appropriate replacement therapy (if such therapy is indicated) are eligible
Active or history of autoimmune disease
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Previous diagnosis of autoimmune disease (Exceptions: patients with autoimmune thyroiditis or vitiligo may be enrolled)
Active or history of autoimmune disease
Autoimmune disease
Active or history of autoimmune disease
Active autoimmune disease.
History of autoimmune disease
History of autoimmune disease
Active uncontrolled autoimmune disease or active inflammatory disease
History of autoimmune disease
History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4]) therapy that has completely resolved for a period of more than 4 weeks
Prior history of uveitis or autoimmune inflammatory eye disease
History of serious autoimmune disease;
Autoimmune disease
History of autoimmune disease
History of or active autoimmune disease
Patients with autoimmune disease
Active systemic infection or autoimmune disease
History of uncontrolled autoimmune disease or on active treatment
Known autoimmune disease
RECIPIENT: Diagnosis with autoimmune disease
History of autoimmune disease
Receiving active treatment for cancer or an autoimmune condition
Active or history of autoimmune disease or immune deficiency
History of autoimmune disease
History of autoimmune disease
Autoimmune diseases or immune deficiency disease
Cancer or autoimmune disease under treatment.
Active autoimmune disease or documented history of autoimmune disease.
Has an active autoimmune disease
History of autoimmune hepatitis
Active or history of autoimmune disease
Subjects with any active autoimmune disease or a history of known autoimmune disease
Active autoimmune disease
Active/uncontrolled autoimmune disease
Active/uncontrolled autoimmune disease
History of autoimmune disease
Active autoimmune disease, motor neuropathy considered of autoimmune origin, or other central nervous system autoimmune disease.
Patients with active autoimmune disease or history of autoimmune disease that might recur should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Participants with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and participants with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; participants with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and participants with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; participants are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease; human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4 > 200, undetectable viral load and on highly active antiretroviral therapy (HAART) therapy
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible
No patients with known active autoimmune disease or known history of autoimmune disease for which recurrence may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis; patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including type I diabetes mellitus or thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune diseases or history of autoimmune diseases should be excluded; these include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematous (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's ulcerative colitis, hepatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Note: Patient are permitted to enroll if they have controlled celiac disease, vitiligo, eczema, psoriasis, controlled Type I diabetes mellitus, endocrine deficiencies (including hypothyroidism) managed with replacement hormones including low-dose (?10 mg/day prednisone equivalents) corticosteroids. Patients with rheumatological autoimmune diseases that are frequently limited in severity such as rheumatoid arthritis and Sjogren's syndrome are permitted to enroll if they do not require treatment with a non-biologic or biologic disease modifying anti-rheumatic drug (DMARDs), e.g. cyclophosphamide or adalimumab. All patients with an autoimmune rheumatological disease require evaluation for severity and target organ involvement.
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded\r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded\r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; however, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n** NOTE: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn's\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* Leptomeningeal disease\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome\r\n* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes but is not limited to: history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. Patients with vitiligo or endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, and psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger (precipitating event) are eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies (other than HTLV-associated arthropathy), and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IRB), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\r\n* NOTE: patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\r\n* Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded \r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome \r\nNOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:\r\n* Immune related neurologic disease\r\n* Multiple sclerosis\r\n* Autoimmune (demyelinating) neuropathy\r\n* Guillain-Barre syndrome\r\n* Myasthenia gravis\r\n* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)\r\n* Connective tissue diseases\r\n* Scleroderma\r\n* Inflammatory bowel disease (IBD)\r\n* Crohn’s\r\n* Ulcerative colitis\r\n* Patients with a history of toxic epidermal necrolysis (TEN)\r\n* Stevens-Johnson syndrome\r\n* Anti-phospholipid syndrome; Note: subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome should be excluded
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
Subjects with active autoimmune disease, a history of known or suspected autoimmune disease or a history of a syndrome requiring systemic corticosteroids (> 10 mg daily of prednisone equivalent) except for the treatment of malignancy with the exception of:\r\n* Isolated vitiligo\r\n* Resolved childhood atopy\r\n* History of a positive antinuclear antibody (ANA) titer without associated symptoms or history of symptoms of an autoimmune disorder\r\n* Controlled thyroid disorders\r\n* Type I diabetes mellitus\r\n* Psoriasis, Sjogren’s syndrome, and arthropathies not requiring systemic treatment\r\n* Autoimmune diseases: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, autoimmune vasculitis, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded