A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

• Adult patients, over the age of 18 years

• Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration

• DAS28 >3.2

• Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68 joint count)

• Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline

• Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)

• Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis

• Prior history of or current inflammatory joint disease other than RA