Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis.

Active, not recruiting

• Conditions: Rheumatoid arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2005-002423-13-BG
• Lead Sponsor: F. Hoffmann La-Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-03
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

•patients who have completed participation in the Phase III study WA17822 in adult rheumatoid arthritis.
•have been receiving methotrexate treatment.

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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

•treatment with any investigational agent since the last administration of study drug in WA17822.
•treatment with iv gammaglobulin, plasmapheresis or Prosorba column since the last administration of study drug in WA17822.
•treatment with an anti-TNF of anti-IL1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822.
•previous treatment with any cell-depleting therapies.
•parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18695.

Study & Design

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