A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)

• Inadequate response to DMARDs

• Body weight < 150 kg

Exclusion Criteria:

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

• Rheumatic autoimmune disease other than RA

• American College of Rheumatology (ACR) functional class IV

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

• Previous treatment with any biologic drug that is used in the treatment of RA

• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

• Pregnant or lactating women

• Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection