Rheumatoid Arthritis | Methotrexate Dose Stable | Age
Item
male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
boolean
C0003873 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Contraceptive methods Quantity | Contraception, Barrier
Item
post menopausal or surgically sterile female patients are allowed. women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0004764 (UMLS CUI [6])
Rheumatoid Arthritis Class Functional | Rheumatoid Arthritis disease length
Item
patients must have a diagnosis of active rheumatoid arthritis of stages i, ii or iii (acr 1987 revised classification for criteria for ra). disease duration of at least 6 months prior to randomization is essential;
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
C0003873 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
anti-tumor necrosis factor therapy | Therapeutic procedure Against Interleukin-1 | Biological treatment
Item
current treatment with anti-tnf-α or anti il-1 therapy (or other biological therapy).
boolean
C0281481 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0021755 (UMLS CUI [2,3])
C1531518 (UMLS CUI [3])
Congestive heart failure | Diabetes mellitus poor control | Glycosylated hemoglobin A
Item
patients with congestive heart failure or poorly controlled diabetes mellitus (hba1c value ≥10%).
boolean
C0018802 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
Autoimmune Diseases inflammatory chronic major | Psoriasis | Arthritis, Psoriatic | Spondylarthropathy | Inflammatory Bowel Diseases | Lupus Erythematosus, Systemic | Autoimmune Disease Interferes with Clinical Trial Evaluation
Item
presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or sle that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
boolean
C0004364 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0033860 (UMLS CUI [2])
C0003872 (UMLS CUI [3])
C0949691 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0024141 (UMLS CUI [6])
C0004364 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0008976 (UMLS CUI [7,3])
C0220825 (UMLS CUI [7,4])
Trauma renal | Glomerulonephritis | Absence of one kidney
Item
history of renal trauma, glomerulonephritis or patient with one kidney.
boolean
C3714660 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0017658 (UMLS CUI [2])
C0426706 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women will be excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Tuberculin (skin test) positive
Item
a positive tuberculin skin test.
boolean
C3161220 (UMLS CUI [1])
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])