Status:
COMPLETED
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NC...
Eligibility Criteria
Inclusion
- Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
Exclusion
- Treatment with any investigational agent since the last administration of study drug in the core studies.
- Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
- Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
- Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
- Previous treatment with any cell-depleting therapies, including investigational agents.
- Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
2067 Patients enrolled
Trial Details
Trial ID
NCT00720798
Start Date
September 1 2005
End Date
April 1 2013
Last Update
September 30 2014
Active Locations (295)
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1
Birmingham, Alabama, United States, 35294-7201
2
Huntsville, Alabama, United States, 35801
3
Mesa, Arizona, United States, 85208
4
Paradise Valley, Arizona, United States, 85253