{
"info": {
"nct_id": "NCT01309282",
"official_title": "Portuguese Observational Re-Treatment Study of MabThera (PORTSMAB) - A Two-centre Observational Study in Sero-positive Rheumatoid Arthritis (RA) Patients Who Are Non-responders or Intolerant to a Single Tumor Necrosis Factor (TNF) Inhibitor",
"inclusion_criteria": "* Adult patients, >/= 18 years of age\n* Rheumatoid arthritis positive for rheumatoid factor and/or anti-CCP\n* Non-responder or intolerant to single TNF-inhibitor therapy\n* Initiating treatment with MabThera/Rituxan\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Contra-indications to MabThera/Rituxan therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adult patients, >/= 18 years of age",
"criterions": [
{
"exact_snippets": "Adult patients, >/= 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adult patients, >/= 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Rheumatoid arthritis positive for rheumatoid factor and/or anti-CCP",
"criterions": [
{
"exact_snippets": "Rheumatoid arthritis positive for rheumatoid factor",
"criterion": "rheumatoid factor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Rheumatoid arthritis positive for ... anti-CCP",
"criterion": "anti-CCP",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Rheumatoid arthritis positive for rheumatoid factor",
"criterion": "rheumatoid factor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Rheumatoid arthritis positive for ... anti-CCP",
"criterion": "anti-CCP",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Non-responder or intolerant to single TNF-inhibitor therapy",
"criterions": [
{
"exact_snippets": "Non-responder ... to single TNF-inhibitor therapy",
"criterion": "response to TNF-inhibitor therapy",
"requirement": {
"requirement_type": "response",
"expected_value": "non-responder"
}
},
{
"exact_snippets": "intolerant to single TNF-inhibitor therapy",
"criterion": "tolerance to TNF-inhibitor therapy",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Non-responder ... to single TNF-inhibitor therapy",
"criterion": "response to TNF-inhibitor therapy",
"requirement": {
"requirement_type": "response",
"expected_value": "non-responder"
}
},
{
"exact_snippets": "intolerant to single TNF-inhibitor therapy",
"criterion": "tolerance to TNF-inhibitor therapy",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Initiating treatment with MabThera/Rituxan",
"criterions": [
{
"exact_snippets": "Initiating treatment with MabThera/Rituxan",
"criterion": "treatment initiation",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"MabThera",
"Rituxan"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Initiating treatment with MabThera/Rituxan",
"criterion": "treatment initiation",
"requirement": {
"requirement_type": "treatment",
"expected_value": [
"MabThera",
"Rituxan"
]
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Contra-indications to MabThera/Rituxan therapy",
"criterions": [
{
"exact_snippets": "Contra-indications to MabThera/Rituxan therapy",
"criterion": "MabThera/Rituxan therapy",
"requirement": {
"requirement_type": "contra-indications",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Contra-indications to MabThera/Rituxan therapy",
"criterion": "MabThera/Rituxan therapy",
"requirement": {
"requirement_type": "contra-indications",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}