Status:
COMPLETED
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate res...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- diagnosed RA for \>=3 months prior to first administration of study medication;
- inadequate response or intolerance to \>=1 anti-TNF therapies, alone or in combination with methotrexate;
- if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for \>=2 weeks prior to start of study.
Exclusion
- other chronic inflammatory diseases;
- use of parental corticosteroids within 4 weeks prior to screening;
- severe heart failure, or severe, uncontrolled cardiac disease.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00424502
Start Date
January 1 2007
End Date
October 1 2009
Last Update
May 9 2016
Active Locations (3)
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1
Budapest, Hungary, 1023
2
Budapest, Hungary, 1027
3
Debrecen, Hungary, 4032