Adult onset Rheumatoid Arthritis Duration
Item
adult-onset ra of at least 6 months but not longer than 15 years in duration as defined by the 1987 american college of rheumatology classification criteria
boolean
C1853562 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Rheumatoid Arthritis | Tender joint count | Swollen joint count | Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
active ra disease as defined by at least 9 tender joints and 9 swollen joints, esr of 30 mm/hour or crp of 1.5 mg/dl
boolean
C0003873 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
Methotrexate Dose Stable U/week | Methotrexate Route of Administration Stable | Folic Acid
Item
mtx (with or without folic acid) for at least 24 weeks prior to the baseline visit, the dose of mtx and route of administration must have been stable for at least 8 weeks prior to the baseline visit. the minimum stable dose of mtx allowed is 10 mg weekly.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0025677 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0016410 (UMLS CUI [3])
Arthritis Other | Arthritis, Psoriatic | Ankylosing spondylitis | Arthritis, Reactive
Item
any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0003872 (UMLS CUI [2])
C0038013 (UMLS CUI [3])
C0085435 (UMLS CUI [4])
Arthritis Secondary Noninflammatory | Osteoarthritis | Fibromyalgia
Item
secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
boolean
C0003864 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0442743 (UMLS CUI [1,3])
C0029408 (UMLS CUI [2])
C0016053 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
nyha (new york heart association) class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tuberculosis
Item
current or history of, tuberculosis
boolean
C0041296 (UMLS CUI [1])
Chronic infectious disease | Communicable Disease Serious | Communicable Disease Life Threatening | Herpes zoster | Sign or Symptom Communicable Disease | Fever | Cough
Item
history of chronic infection, recent serious or life-threatening infection (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0019360 (UMLS CUI [4])
C3540840 (UMLS CUI [5,1])
C0009450 (UMLS CUI [5,2])
C0015967 (UMLS CUI [6])
C0010200 (UMLS CUI [7])
High risk of Communicable Disease
Item
high risk of infection
boolean
C0332167 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Therapy, Investigational | Exception Biological treatment | Study Subject Participation Status
Item
have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to baseline
boolean
C0949266 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1531518 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
B cell therapy | rituximab
Item
have received previous b-cell therapy (eg. rituximab)
boolean
C0545321 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Biological treatment Rheumatoid Arthritis | Exception Etanercept Associated with Washout Period
Item
have received any other biological therapy for ra within 24 weeks prior to baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C0332281 (UMLS CUI [2,3])
C1710661 (UMLS CUI [2,4])
Biological treatment Rheumatoid Arthritis | Result Severe allergic reaction | Result Anaphylaxis
Item
have received previous treatment with a biological therapy for ra that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2220378 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0002792 (UMLS CUI [3,2])
Anti-TNF drug Unresponsive to Treatment
Item
failed to respond to previous treatment with an anti-tnf drug
boolean
C1562242 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])