A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.
- Conditions
- Rheumatoid ArthritisMedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2009-012759-12-AT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1128
- adult patients at least 18 years of age with moderate to severe active RA of <2 years disease duration.
- no previous methotrexate or biologic agent.
- DMARDs should be withdrawn at least 2 weeks prior to baseline.
- 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 981
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147
- major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study.
- treatment with methotrexate at anytime prior to baseline.
- treatment with a biologic at anytime prior to baseline.
- Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds.
- women who are pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To assess the efficacy of treatment with TCZ monotherapy and TCZ + MTX combination therapy, versus MTX monotherapy, with regard to the following primary endpoint in patients with early, moderate to severe rheumatoid arthritis (RA):<br>•Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 6 months.<br>;Secondary Objective: • Prevention of structural joint damage over 12 months and maintenance of this effect at 24 months.<br>• Improvement in physical function over 12 months and maintenance of this effect at 24 months.<br>• Pharmacokinetics, immunogenicity and pharmacodynamics of TCZ in patients with early RA<br>• Safety and efficacy of TCZ administration in patients with early RA.<br>;Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24.;Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): change in total modified Sharp score (Time Frame: week 52)<br>clinical response: ACR20/ACR50/ACR70 (Time Frame: weeks 24 and 52)<br>physical function: HAQ-DI score (Time Frame: weeks 24 and 52)<br>;Timepoint(s) of evaluation of this end point: weeks 24 and 52