A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.
Phase 1
- Conditions
- Rheumatoid ArthritisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2004-003733-14-FI
- Lead Sponsor
- F. Hoffmann La-Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1170
Inclusion Criteria
- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months
- inadequate response to a stable dose of MTX
-patients of reproductive potential must be using reliable methods of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1009
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 187
Exclusion Criteria
- major surgery (including joint surgery) within eight weeks before entering study, or planned surgery within 6 months after entering study
-prior treatment failure with an anti-tumor necrosis factor agent
- women who are prgenant or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method