Patient has any concurrent autoimmune disease or has a history of chronic or recurrent autoimmune disease; these include but are not limited to: multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura
History of chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc) with symptomatic disease within the last 3 years; Note: active vitiligo or alopecia or a history of vitiligo or alopecia will not be a basis for exclusion
Subject with a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Subjects with vitiligo, endocrinopathies, and alopecia are allowed. Subjects with psoriasis not requiring systemic treatment within the past 6 months are allowed;
Subject has active, known or suspected autoimmune disease, including systemic lupus erythematodes, Hashimoto thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis
Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment; hypothyroidism without evidence of Grave’s disease or Hashimoto’s thyroiditis is permitted
May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
History of autoimmune disease including rheumatoid arthritis, systemic lupus and sarcoidosis
Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus (SLE), and Sjogren’s syndrome, sarcoidosis; asthma or chronic obstructive pulmonary disease (COPD) that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
Study subjects with known autoimmune disease (e.g. systemic lupus erythematosus [SLE], rheumatoid arthritis [RA]) who have had significant symptoms within the past 3 years. Study subjects with vitiligo are not excluded
Clinically active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE]) requiring treatment; vitiligo, diabetes, or treated thyroiditis are allowed
History of autoimmune disease including, but not limited to:\r\n* Systemic lupus erythematosus (SLE), scleroderma, calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome, rheumatoid arthritis\r\n* Inflammatory bowel disease, celiac disease, primary biliary cirrhosis, autoimmune hepatitis\r\n* Dermatomyositis, polymyositis, giant cell arteritis\r\n* Autoimmune hemolytic anemia (AIHA), cryoglobulinemia, antiphospholipid antibody syndrome (APLS)\r\n* Diabetes mellitus type I, myasthenia gravis, Grave’s disease\r\n* Wegener’s granulomatosis or other vasculitis\r\n* A history of Hashimoto’s thyroiditis, psoriasis, or eczema, any of which has been inactive for at least one year, or isolated Raynaud’s phenomenon is acceptable
History of inflammatory bowel disease or other serious autoimmune disease; (not including thyroiditis and rheumatoid arthritis); patients already on hydroxychloroquine for such disorders are not eligible
Systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma)
Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; autoimmune-related thyroid disease, type I diabetes and vitiligo are permitted if the condition is well controlled
Auto-immune disease including inflammatory bowel disease, lupus, rheumatoid arthritis, but not including hypothyroidism or psoriasis if condition has been stable for 2 months or greater
History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
Autoimmune disease requiring treatment within the last 5 years including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, uveitis, or other if clinically significant
History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
Clinical diagnosis of systemic lupus erythematosus (SLE); or other autoimmune disorders with anti-nuclear antibodies at Screening
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease\r\n** Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n** Patients with diabetes type I, vitiligo, or alopecia are allowed\r\n* Other immunodeficiency diseases\r\n* Splenectomy
No history of or current diagnosis of a 'significant autoimmune disease” or paraneoplastic autoimmune disease, i.e. myasthenia gravis, Lambert-Eaton, systemic lupus, rheumatoid arthritis. For minor 'autoimmune' disorders such as psoriasis, arthritis (not including rheumatoid arthritis), Reynauld’s disease; these are allowed onto trial.
Autoimmune disorders (e.g., Crohn’s disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system except patients who have grade 1 psoriasis (in remission or controlled with topical steroids) or mild degree of autoimmune thyroiditis that are controlled with medications
Patients with a history of autoimmune disease (e.g., rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Patients with vitiligo or alopecia are allowed. Patients with Graves disease or psoriasis not requiring systemic treatment within the past 2 years are allowed.
May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus; Note: vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed
Active on-going immunologic or autoimmune disease including but not limited to systemic or cutaneous lupus erythematosus, cutaneous psoriasis, psoriatic arthritis, rheumatoid arthritis, scleroderma, sicca syndrome, polymyalgia rheumatica, polyarteritis nodosa, granulomatous polyangiitis, microscopic polyangiitis, polyarteritis nodosa, temporal arteritis, giant cell arteritis, dermatomyositis, Kawasaki disease
Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.
Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; in the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable; additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed; patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligible
History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
History of or active autoimmune disorders (including but not limited to: Crohn’s disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave’s disease) and other conditions that compromise or impair the immune system
History or presence of a 2nd autoimmune disease requiring immunosuppressive therapy that has substantial risk of immunosuppressive treatment beyond transplant with the following exceptions:\r\n* History and/or presence of Sjogren's Syndrome is allowed\r\n* Stable myositis (A history of myositis that is clinically stable as defined by lack of progressive proximal muscle weakness and a stable or decreasing creatine phosphokinase [CPK] < 3 x ULN) is allowed\r\n* The presence of anti-double stranded (ds)-deoxyribonucleic acid (DNA) without clinical systemic lupus erythematosus in a patient with a diagnosis of otherwise \pure\ SSc is allowed\r\n* Concomitant rheumatoid arthritis without extra-articular disease characteristic of rheumatoid arthritis is allowed
History of autoimmune disease, such as, but not restricted to: rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years; patients with vitiligo or diabetes are not excluded; replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; patients with recent history of thyroiditis; subjects with remote history (greater than 5 years) of thyroiditis are not excluded
Autoimmune diseases such as rheumatoid arthritis are NOT allowed; vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed
Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjogren syndrome, and sarcoidosis)
Autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, that is active and requires current immunosuppressive therapy
History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Graves disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases
Prior diagnosis of rheumatoid arthritis
Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen); such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn’s disease and temporal arteritis
No prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease including Addison’s disease, Grave’s disease, Hashimoto’s thyroiditis, hypophysitis, uveitis); asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; active vitiligo or alopecia, or a history of vitiligo or alopecia is acceptable
Medical conditions that may increase risk for poor cosmetic outcome (i.e. lupus, rheumatoid arthritis, scleroderma)
Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma)
Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's disease, multiple sclerosis (MS), ankylosing spondylitis)
History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis, sarcoidosis or connective tissue disorders (including rheumatoid arthritis and systemic lupus erythematosus)
Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjorgen’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligible
Medical history of vasculitis or lupus erythematosus
Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the PI to determine if eligible
History of autoimmune diseases (such as systemic lupus erythematosus [SLE], Wegener's, Wegener's granulomatosis, polyarteritis nodosa); Note: Prior autoimmune diseases are allowed as long as clinically stable
Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligible
Systemic collagen vascular disease including scleroderma or systemic lupus erythematosus (SLE); rheumatoid arthritis is eligible
History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
Pre-existing autoimmune or antibody -mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, history of uveitis; patients with controlled thyroid disease, or the presence of auto-antibodies without clinical autoimmune disease, are permitted on study
Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
Presence of other known significant autoimmune or inflammatory disease; examples include major chronic infectious/inflammatory/immunologic diseases such as systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome and periodic fever syndromes
Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves’ disease, or Hashimoto’s thyroiditis
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (example [e.x.]: fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
Active autoimmune disease including but not limited to: rheumatoid arthritis (RA), inflammatory bowel disease (IBD), celiac disease, systemic lupus erythematosus (SLE), scleroderma or multiple sclerosis; patients with autoimmune hypothyroidism or type I diabetes mellitus will be eligible; patients who are seropositive only without clinical symptoms will not be excluded
Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome; at the discretion of the treating physician patients who show disease control for at least 6 months may be enrolled
Documented history of certain autoimmune diseases such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis).
No prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable
Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
Clinical diagnosis of systemic lupus erythematosus (SLE); or other autoimmune disorders with anti-nuclear antibodies at Screening
Clinical diagnosis of systemic lupus erythematosus (SLE) or other autoimmune disorders with anti-nuclear antibodies (ANAs) at Screening
Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).
History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease\r\nor any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines.
Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
Active autoimmune process (eg rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who have been receiving therapy for an autoimmune or inflammatory disease; vitiligo, thyroiditis, or eczema is permitted if patient is otherwise eligible
Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis
Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
History of immunodeficiency (e.g., human immunodeficiency virus [HIV]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy
History of autoimmune disorder (e.g. hepatitis; idiopathic thrombocytopenic purpura [ITP]; scleroderma; severe psoriasis affecting > 10% of the body, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory drugs [NSAID] for management)
Current or history of systemic autoimmune disease requiring systemic therapy\r\n* Note: the following will NOT be exclusionary:\r\n** The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms\r\n** Clinical evidence of vitiligo or other forms of depigmenting illness\r\n** Mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis)
History of pre-existing immunodeficiency disorder, autoimmune condition requiring immunosuppressive therapy, or chronic infection (i.e. hepatitis B, hepatitis C, human immunodeficiency syndrome virus [HIV]); this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines
Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
Rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis
Active autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogren’s syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within 4 weeks prior to the screening visit, with the exception of thyroid replacement
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves' disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc
Autoimmune- or antibody (Ab)-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis
History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.g. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
Active or history of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, polymyositis, sarcoidosis, etc.) with symptomatic disease within the 2 years before randomization; Note: subjects with vitiligo, Graves' disease or psoriasis not requiring systemic treatment within the past 2 years will not be excluded
Active autoimmune disease, defined as any autoimmune condition currently requiring therapy (e.g., systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis)
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases\r\n* Splenectomy
History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen’s syndrome, vasculitis/arteritis, Behcet’s syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis; (vitiligo is allowed)
Systemic autoimmune disease (e.g., systemic lupus erythematosus, active rheumatoid arthritis, Marfan Syndrome, etc.).
Patients receiving treatment for active autoimmune disease. \Active\ refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
Diagnosis of autoimmune disease (i.e., rheumatoid arthritis, scleroderma, systemic lupus erythematosus [SLE], autoimmune vasculitis, Guillain-Barre syndrome, etc.), regardless if patient is currently receiving treatment at time of registration/randomization
Diagnosis of autoimmune disease, including, but not limited to:\r\n* Systemic lupus erythematosus (lupus)\r\n* Multiple sclerosis (MS)\r\n* Rheumatoid arthritis (RA)\r\n* Ankylosing spondylitis\r\n* Other autoimmune disease (specify)
Patients with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing spondylitis)
History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
Immunocompromised status due to:\r\n* Human immunodeficiency virus (HIV) positivity\r\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed\r\n* Other immunodeficiency diseases
History of, or active autoimmune disease (such as autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjögrens syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, Crohn's or Graves' disease); patients with type 1 diabetes mellitus or vitiligo are not excluded if the condition is well controlled
History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
Known active autoimmune disease will be excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
Patients must not be receiving treatment for rheumatoid arthritis or systemic lupus erythematosus
History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; prior history of autoimmune thyroiditis or vitiligo is permitted
Comorbid conditions: Addison’s disease, autoimmune hepatitis, hepatitis B, hepatitis C, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
Any patient currently requiring or anticipated to require tumor necrosis factor (TNF) blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis)
Presence of rheumatoid arthritis
History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; patients receiving replacement thyroid hormone would be eligible
Active autoimmune disease requiring active therapy with any form of steroid or immunosuppressive therapy or a documented history of any of the following: inflammatory bowel disease; regional enteritis systemic lupus erythematosus; Sjogren's syndrome; inflammatory neurologic disorder such as multiple sclerosis; or any immune mediated disease that can cause life-threatening symptoms or severe organ/tissue damage in the opinion of the principle investigator
Pre-existing autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring anti-inflammatory therapy
Autoimmune diseases such as the following: autoimmune neutropenia, thrombocytopenia, hemolytic anemia, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome, Addison’s disease, Hashimoto’s thyroiditis, or active Graves’ disease
Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
Pre-existing autoimmune or antibody mediated disease including: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, Addison's disease, but excluding the presence of autoantibodies without clinical autoimmune disease
Active autoimmune disease or condition requiring chronic immunosuppressive therapy (e.g., rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)\r\n* NOTE: abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary
Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
Active autoimmune disease such as Crohn’s disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditions
Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
Known history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;
Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj?gren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
Patient has an autoimmune condition, including, but not limited to, multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura.
History of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity eg rheumatoid arthritis or thyroiditis may be allowed per Principal Investigator (PI) discretion provided it has been quiescent for a minimum of three years
Patients with active autoimmune disease; “active” refers to any condition currently requiring therapy; examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis
Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis
Known history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosa
The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease. Patients with vitiligo are not excluded.
The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease.
Inflammatory arthritis that requires disease modifying drugs (e.g. rheumatoid arthritis)
Confirmed or suspected diagnosis of the following rheumatological autoimmune diseases or immune compromised status: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
Patients with a systemic disease that could affect their bone marrow or peripheral blood cells (e.g. systemic lupus erythematosus, human immunodeficiency virus infection, rheumatoid arthritis)
Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
Advanced rheumatoid arthritis
Patients with chronic active arthritis
Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone; patients with\r\nosteoarthritis are eligible
Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years
Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosus, rheumatoid arthritis
Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget's disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis
History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), Parkinson’s disease and cancer involving the bone
CONTROL (HEALTHY) GROUP: Inflammatory conditions, such as rheumatoid arthritis, systemic lupus or inflammatory bowel disease
History of or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus, localized lupus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome, Addison’s disease, Hashimoto’s thyroiditis, or Graves disease); persons with vitiligo are not excluded
Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, human immunodeficiency virus [HIV])
History of or active autoimmune disease including but not limited to autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosus, Sjogren’s syndrome, scleroderma, myasthenia gravis, Goodpasture’s syndrome; persons with vitiligo are not excluded; Persons with well-controlled autoimmune endocrinopathies, e.g., diabetes mellitus, Graves’ disease, Hashimoto’s thyroiditis, Addison’s disease are not excluded; persons with well-controlled rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica are not excluded
History of auto?immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto’s thyroiditis, or Grave’s disease
Patients with various autoimmune disorders (including rheumatoid arthritis?RA, Crohn’s disease, systemic lupus erythematosus–SLE, Takayasu arthritis)
Diagnosis of rheumatoid arthritis by a rheumatologist (randomized controlled trial [RCT])
Patients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.
History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.