Sign or Symptom Arthritis Duration
Item
signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening.
boolean
C3540840 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Swollen joint count
Item
presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms.
boolean
C0451521 (UMLS CUI [1])
Synthetic Disease-Modifying Antirheumatic Drugs
Item
synthetic disease-modifying antirheumatic drugs dmard use as follows:
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
Tofacitinib | Tofacitinib Planned
Item
any treatment with tofacitinib within 28 days prior to baseline or planned treatment with tofacitinib during the study;
boolean
C2930696 (UMLS CUI [1])
C2930696 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Synthetic Disease-Modifying Antirheumatic Drugs Dose Unstable | Synthetic Disease-Modifying Antirheumatic Drugs Change in drug dosage Planned | Hydroxychloroquine | Methotrexate | leflunomide | Sulfasalazine | Gold salt
Item
treatment with other synthetic dmards (eg, hydroxychloroquine, methothrexate, leflunomide, sulfasalazine, and gold salts) at an unstable dose within 28 days prior to baseline or if the dose of drug is planned to be changed during the study.
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0443343 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2,1])
C1883254 (UMLS CUI [2,2])
C0420247 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
C0020336 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C0036078 (UMLS CUI [6])
C0302210 (UMLS CUI [7])
Biologic Disease-Modifying Antirheumatic Drug
Item
previous treatment with marketed biologic dmards as follows:
boolean
C4055380 (UMLS CUI [1])
Etanercept | adalimumab | anakinra
Item
etanercept, adalimumab, or anakinra <4 weeks prior to baseline;
boolean
C0717758 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
C0245109 (UMLS CUI [3])
infliximab | certolizumab pegol | golimumab | abatacept | tocilizumab
Item
infliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab <8 weeks prior to baseline;
boolean
C0666743 (UMLS CUI [1])
C1872109 (UMLS CUI [2])
C2353893 (UMLS CUI [3])
C1619966 (UMLS CUI [4])
C1609165 (UMLS CUI [5])
rituximab
Item
rituximab <12 months prior to baseline
boolean
C0393022 (UMLS CUI [1])
Exception Indication Arthritis | Biological agents allowed
Item
note: other biologic agents for indications other than an inflammatory arthritis may be allowed after discussion with the sponsor
boolean
C1705847 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C0005515 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Prednisone Oral U/day | Prednisone Oral Dose Unstable | Prednisone Oral Equivalent U/day | Prednisone Oral Equivalent Dose Unstable
Item
treatment with >10 mg/day, or unstable dose, of oral prednisone or equivalent within 28 days prior to baseline.
boolean
C3216040 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C3216040 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C3216040 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C3216040 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0443343 (UMLS CUI [4,4])
Septic Arthritis | Septic Arthritis Suspected | Crystal Arthropathy | Lupus Erythematosus, Systemic | Arthritis, Reactive | Rheumatic disorder
Item
confirmed or suspected septic arthritis, crystal arthropathy, systemic lupus erythematosus, reactive arthritis, or certain other rheumatic conditions.
boolean
C0003869 (UMLS CUI [1])
C0003869 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0152087 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0085435 (UMLS CUI [5])
C3495832 (UMLS CUI [6])