A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00106574
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. 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
- 1220
Inclusion Criteria
- patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
- stable DMARD therapy for at least 8 weeks before entering study;
- 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 surgery within 6 months after entering study;
- patients who have previously failed treatment with an anti-tumor necrosis factor agent;
- 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 Placebo -
- Primary Outcome Measures
Name Time Method Percentage of patients with ACR 20 response Week 24
- Secondary Outcome Measures
Name Time Method Percentage of patients with ACR 50 and ACR 70 responses. Week 24 Mean changes in parameters of ACR core set Week 24 AEs, laboratory parameters, vital signs. Throughout study