A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2014-01-28
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.