Rheumatoid Arthritis | disease length
Item
diagnosis of rheumatoid arthritis ≥3 months duration. american college of rheumatology (acr) class i-iii functional status.
boolean
C0003873 (UMLS CUI [1])
C0872146 (UMLS CUI [2])
Rheumatoid Arthritis Active
Item
active ra defined as:
boolean
C0003873 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Joint swelling | Joint tenderness
Item
at least 6 of 66 swollen joints and 8 of 68 tender joints,
boolean
C0152031 (UMLS CUI [1])
C0240094 (UMLS CUI [2])
C-reactive protein; high sensitivity (hsCRP) | Erythrocyte sedimentation rate measurement
Item
high sensitivity c-reactive protein (hs-crp) ≥8 mg/l or esr ≥28 mm/h, and
boolean
C0973334 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Disease activity score 28 joint in rheumatoid arthritis Erythrocyte sedimentation rate measurement | Medical contraindication Therapeutic procedure Methotrexate | Methotrexate Disease Response Inadequate
Item
das28esr >5.1. patients who per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (mtx), or after at least 12 weeks of continuous treatment with mtx, or inadequate responders treated with an adequate mtx dose for at least 12 weeks.
boolean
C2732493 (UMLS CUI [1,1])
C1176468 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0025677 (UMLS CUI [2,3])
C0025677 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
Age | age subdivision of legal significance | Informed Consent
Item
age <18 years or the legal age of consent in the country of the study site, whichever is higher.
boolean
C0001779 (UMLS CUI [1])
C0682055 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Therapeutic procedure Antirheumatic Drugs, Disease-Modifying | Therapeutic procedure Immunosuppressive Agents | Methotrexate | Cyclosporine | MYCOPHENOLATE | Tacrolimus | Gold | Penicillamine | Sulfasalazine | Hydroxychloroquine | Azathioprine | Cyclophosphamide | leflunomide | Cholestyramine Washout
Item
current treatment with disease-modifying antirheumatic drug (dmards)/immunosuppressive agents including mtx, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (randomization visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (randomization visit) or leflunomide within 8 weeks prior to the randomization visit, or 4 weeks after cholestyramine washout.
boolean
C0087111 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0021081 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0883242 (UMLS CUI [5])
C0085149 (UMLS CUI [6])
C0018026 (UMLS CUI [7])
C0030817 (UMLS CUI [8])
C0036078 (UMLS CUI [9])
C0020336 (UMLS CUI [10])
C0004482 (UMLS CUI [11])
C0010583 (UMLS CUI [12])
C0063041 (UMLS CUI [13])
C0008402 (UMLS CUI [14,1])
C1710661 (UMLS CUI [14,2])
Biological Agents Previous | Interleukin-6 Antagonist | Interleukin-6 Receptor Antagonist | Prior Therapy Janus kinase inhibitor
Item
treatment with any prior biologic agent, including anti-interleukin 6 (il-6), il-6 receptor (il-6r) antagonists, and prior treatment with a janus kinase inhibitor.
boolean
C0005515 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3864917 (UMLS CUI [2])
C3819026 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C3854325 (UMLS CUI [4,2])
Parenteral steroid treatment | intraarticular injection of corticosteroids
Item
use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
boolean
C3840673 (UMLS CUI [1])
C2064783 (UMLS CUI [2])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])