Status:
COMPLETED
A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). ...
Detailed Description
The primary objective of this extension study was to assess the long-term safety of 8 mg/kg tocilizumab with regard to adverse events (AEs) and laboratory result abnormalities. The secondary objectiv...
Eligibility Criteria
Inclusion
- Patients who have completed participation in the Phase III study WA17822 (NCT00106548) in adult rheumatoid arthritis.
Exclusion
- Treatment with any investigational agent since the last administration of study drug in WA17822.
- Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column since the last administration of study drug in WA17822.
- Treatment with an anti-tumor necrosis factor or anti-interleukin-1 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
538 Patients enrolled
Trial Details
Trial ID
NCT00721123
Start Date
August 1 2005
End Date
May 1 2012
Last Update
November 28 2013
Active Locations (69)
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1
Buenos Aires, Argentina, 1405
2
Buenos Aires, Argentina, C1015ABO
3
Buenos Aires, Argentina, C1428DQG
4
Adelaide, Australia, 5041