A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies

• Conditions: Rheumatoid arthritis; MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2005-002909-23-CZ
• Lead Sponsor: F Hoffmann La-Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-13
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2420

Inclusion Criteria

•patients who have completed participation in one of the core studies (e.g. WA17824, WA18062, WA18063, and WP18663) in adult rheumatoid arthritis.
•inadequate response to a stable dose of MTX or other allowable Disease Modifying Anti-Rheumatic Drug (DMARD).
•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 1711
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 357

Exclusion Criteria

•treatment with any investigational agent since the last administration of study drug in core studies.
•treatment with iv gamma globulin, plasmapheresis or prosorba column since the last administration of study drug in core studies.
•treatment with an anti-tumor necrosis factor agent or anti-IL-1 agent, or a T-cell costimulation modulator or any biologic since the last administration of study drug in the core studies.

Study & Design

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