A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00109408
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 673
Inclusion Criteria
- adult patients at least 18 years of age with active RA for at least 3 months;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
- major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
- treatment with methotrexate (MTX) within 6 months of entering study;
- patients who have stopped previous MTX treatment due to toxicity or lack of response;
- women who are pregnant or breast-feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tocilizumab [RoActemra/Actemra] - 2 Methotrexate -
- Primary Outcome Measures
Name Time Method Percentage of patients with ACR 20 response Week 24
- Secondary Outcome Measures
Name Time Method Mean change in parameters of ACR core set Week 24 AEs, laboratory parameters, vital signs. Throughout study Percentage of patients with ACR 50 and ACR 70 responses Week 24 Percentage of patients with ACR 20 response Week 8