Rheumatoid Arthritis
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of RA for >=6 months according to the revised 1987 ACR criteria for the classification of RA. - Receiving methotrexate at a dose of 6 to 8 mg/week(oral) for >=12 weeks, with a stable dose for the last 4 weeks before treatment. - Positive serum RF.
Exclusion criteria
Exclusion criteria: - Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA. Patients with secondary Sjogren's syndrome or secondary limited cutaneous vasculitis with RA are eligible. - Functional Class IV as defined by the ACR Classification of Functional Status in RA. - History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder. - Any surgical procedure within 12 weeks prior to or planned within 24 weeks after baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR20 response at week 24. | — |