A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients ≥ 18 years of age.
Rheumatoid arthritis of ≤ 2 years duration.
Disease Activity Score 28 (DAS28) \> 3.2.
Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative \> 1 erosion required at screening).
Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
You may not be if
Previous treatment with tocilizumab.
Previous treatment with methotrexate or biologic agent.
Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
History of or current inflammatory joint disease other than RA.
Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
Clareo Health | A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis