Rheumatoid Arthritis
Item
diagnosed with rheumatoid arthritis (ra) at least 3 months prior to study start based upon the american college of rheumatology (acr) 1987 revised criteria.
boolean
C0003873 (UMLS CUI [1])
Methotrexate Oral Product Dose Stable U/week | Methotrexate Injectable Product Dose Stable U/week | Folate U/week
Item
on a stable weekly dose of both methotrexate (mtx) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C3216565 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0560588 (UMLS CUI [2,4])
C0178638 (UMLS CUI [3,1])
C0560588 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
meets the acr 1991 revised criteria for global functional status in ra, class i, ii, or iii.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Therapeutic procedure Specified | Washout Period Completed
Item
completed an appropriate washout period if treated with specified therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1710661 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Standard of Care Dose Stable Rheumatoid Arthritis
Item
patients may continue on specified stable background therapy for ra (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with sponsor approval).
boolean
C2936643 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003873 (UMLS CUI [1,4])
Inclusion criteria Additional
Item
additional criteria exist.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Arthritis Interferes with Assessment of disease activity | Arthritis Noninflammatory Interferes with Assessment of disease activity | Spondylarthritis | Fibromyalgia | Arthritis, Psoriatic | Gout | Osteoarthritis Affecting Evaluation
Item
diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
boolean
C0003864 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C4064989 (UMLS CUI [1,3])
C0003864 (UMLS CUI [2,1])
C0442743 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C4064989 (UMLS CUI [2,4])
C0949690 (UMLS CUI [3])
C0016053 (UMLS CUI [4])
C0003872 (UMLS CUI [5])
C0018099 (UMLS CUI [6])
C0029408 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0220825 (UMLS CUI [7,3])
Prior Therapy
Item
has received any of the following prior treatments:
boolean
C1514463 (UMLS CUI [1])
anakinra | Kineret | Etanercept | Enbrel
Item
1. within 4 weeks of first dose of study drug: anakinra (kineret®), etanercept (enbrel®);
boolean
C0245109 (UMLS CUI [1])
C1170364 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C0720193 (UMLS CUI [4])
infliximab | Remicade | adalimumab | Humira | leflunomide | Arava
Item
2. within 8 weeks of first dose of study drug: infliximab (remicade®), adalimumab (humira®), leflunomide (arava®);
boolean
C0666743 (UMLS CUI [1])
C0723012 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
C1171255 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C0718644 (UMLS CUI [6])
rituximab | Rituxan | alemtuzumab | Campath | Investigational New Drugs Targeting B cells
Item
3. at any time: rituximab (rituxan®), alemtuzumab (campath®), any experimental b cell targeting agents.
boolean
C0393022 (UMLS CUI [1])
C0732355 (UMLS CUI [2])
C0383429 (UMLS CUI [3])
C0939276 (UMLS CUI [4])
C0013230 (UMLS CUI [5,1])
C1521840 (UMLS CUI [5,2])
C0004561 (UMLS CUI [5,3])
CYP3A Inhibitors | CYP3A Inducers | Antirheumatic Drugs, Disease-Modifying | Biological Response Modifiers
Item
treatment with potent cyp3a inhibitors or inducers, disease-modifying antirheumatic drugs (dmards) and/or biologic response modifiers (brms) during the study.
boolean
C3850056 (UMLS CUI [1])
C3850044 (UMLS CUI [2])
C0242708 (UMLS CUI [3])
C0005525 (UMLS CUI [4])
Exclusion Criteria Additional
Item
additional criteria exist.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])