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An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.
This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Canberra, Australian Capital Territory, Australia
Coffs Harbour, New South Wales, Australia
Kogarah, New South Wales, Australia
Cairns, Queensland, Australia
Adelaide, South Australia, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Edmonton, Alberta, Canada
Lethbridge, Alberta, Canada
Start Date
March 1, 2009
Primary Completion Date
April 1, 2012
Completion Date
April 1, 2012
Last Updated
August 6, 2014
934
ACTUAL participants
tocilizumab [RoActemra/Actemra]
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07484243
NCT06647069
Data Source & Attribution
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