Status:
COMPLETED
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rhe...
Eligibility Criteria
Inclusion
- adult patients, \>/= 18 years of age
- moderate to severe active rheumatoid arthritis of \>/=6 months duration
- inadequate clinical response to current non-biologic DMARDs
- current DMARDs must be at stable dose for 8 weeks prior to study entry
- oral corticosteroids (\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \>/=4 weeks prior to screening
Exclusion
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any biologic DMARD
- functional class IV as defined by the ACR classification
- intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Key Trial Info
Start Date :
October 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2011
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00996203
Start Date
October 31 2009
End Date
February 14 2011
Last Update
March 29 2018
Active Locations (28)
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1
Chelyabinsk Regional Clinical Hospital; Rheumatology
Chelyabinsk, Russia, 454076
2
Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
Cherkess, Russia, 369000
3
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
Irkutsk, Russia, 664047
4
Republican Clinicodiagnostic Center
Izhevsk, Russia, 426009