A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis
- Conditions
- Rheumatoid arthritis (RA)MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2010-019912-18-GR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
- Adult patients, >/=18 years of age
- Moderate to severe rheumatoid arthritis of >/=6 months duration
- Receiving treatment on an outpatient basis
- Swollen joint count (SJC) >/=6 (66 joint count) and tender joint count (TJC) >/=8 (68 joint count) at screening and study start
- On a stable dose of disease-modifying antirheumatic drugs for at least 8 weeks prior to study start
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's syndrome with rheumatoid arthritis is allowed
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - Reduction in disease activity according to American College of Rheumatology (ACR) 20 criteria at week 24<br><br>- Safety of treatment with TCZ vs placebo;Secondary Objective: - Prevention of progression of structural damage at Week 24 and Week 48<br>- Improvement of physical function<br>- Long-term safety and efficacy<br>- Pharmacokinetics (PK) and pharmacodynamics (PD) of TCZ SC <br>- Immunogenicity of TCZ SC<br><br>;Primary end point(s): The proportion of patients with an ACR20 response at week 24.<br>
- Secondary Outcome Measures
Name Time Method