Age
Item
male and female patients aged 18.5 - 65/75 years (depending on the dose group).
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis disease length
Item
diagnosis of rheumatoid arthritis (acr 1987 revised classification for criteria for ra) with a disease duration of at least 6 months prior to randomization.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Disease | Evaluation | Joints tender Quantity | Joints swollen Quantity | Examination of joint Quantity | Hydrarthrosis | Sedimentation rate, Westergren | C-reactive protein measurement
Item
active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) westergren erythrocyte sedimentation (esr) ≥ 28 mm/hour, or b) crp ≥ 6 mg/l.
boolean
C0012634 (UMLS CUI [1])
C1261322 (UMLS CUI [2])
C0240094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0152031 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0562263 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1253936 (UMLS CUI [6])
C0200705 (UMLS CUI [7])
C0201657 (UMLS CUI [8])
Disease-Modifying Antirheumatic Drugs Quantity failed
Item
patients should have failed at least 1 dmard in the past, but should not be deemed "refractory to all therapies"
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Methotrexate Dose Stable U/week
Item
patients should have a current treatment regimen of ≥ 15 mg methotrexate/week and with the current dose stable for approximately 3 months.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Therapeutic procedure Stable Rheumatoid Arthritis | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day
Item
patients were required to have an otherwise stable ra therapeutic regimen, consisting of either a stable dose of nsaids and/or a stable dose of oral corticosteroids (prednisone or equivalent < 10 mg daily) for at least 4 weeks prior to randomization.
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0032952 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0032952 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
anti-tumor necrosis factor therapy | Biological treatment
Item
previous treatment with anti-tnf-α antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound)
boolean
C0281481 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
intraarticular injection of corticosteroids | corticosteroids injection Systemic | Therapeutic procedure Flare of rheumatoid arthritis Patient need for | Narcotic Analgesics Patient need for | Analgesia | Codeine | Tramadol | Propoxyphene
Item
patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute ra flare (not being part of a regular therapeutic regimen) within four weeks prior to randomization or require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene)
boolean
C2064783 (UMLS CUI [1])
C2095490 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0581345 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
C0027409 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C3202977 (UMLS CUI [5])
C0009214 (UMLS CUI [6])
C0040610 (UMLS CUI [7])
C0033493 (UMLS CUI [8])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])