A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, at least 18 years of age, inclusive

• Diagnosis of rheumatoid arthritis of at least 6 months duration

• Moderate to severe active rheumatoid arthritis (DAS28 >/=3.2)

• Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization

• Rheumatic autoimmune disease other than rheumatoid arthritis

• Prior history of or current inflammatory joint disease other than rheumatoid arthritis

• Functional class IV (ACR criteria)

• History of severe allergic reaction to human, humanized or murine monoclonal antibodies

• Known active current or history of recurrent infection (including tuberculosis)

• Primary or secondary immunodeficiency (history of or currently active)

• Body weight >150 kg

• Previous treatment with any cell-depleting therapies

• Previous treatment with tocilizumab