Status:
COMPLETED
A Study of Tocilizumab in Patients With Rheumatoid Arthritis
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.
Detailed Description
This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are s...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Moderately to severely active rheumatoid arthritis
- Inadequate response to previous treatment with an anti-TNF agent
- Receiving methotrexate for at least 12 wks before study
Exclusion
- Previous treatment with tocilizumab
- Previous treatment with other IL-6 receptor inhibitors
- Treatment with corticosteroids (oral prednisone \>10 mg/day or equivalent) within 4 wks
- Conditions noted in the tocilizumab prescribing information
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01187563
Start Date
August 1 2010
End Date
December 1 2010
Last Update
October 13 2011
Active Locations (2)
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1
Worcester, Massachusetts, United States
2
Duncansville, Pennsylvania, United States