Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2008-001847-20-LV
• Lead Sponsor: F Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

•adult patients, >=18 years of age;
•moderate to severe active rheumatoid arthritis (DAS28 >4.4);
•inadequate response to methotrexate;
•on a stable dose of >=15mg/week methotrexate for at least 6 weeks.

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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 106

Exclusion Criteria

•prior treatment with a biologic;
•RA functional class IV;
•known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
•evidence of active malignant disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified