Status:
COMPLETED
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients wil...
Eligibility Criteria
Inclusion
- adult patients \>/= 18 years of age
- rheumatoid arthritis DAS28 \>/= 3.2
- receiving treatment on an outpatient basis
- experienced an inadequate response to previous or current treatment with methotrexate
Exclusion
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any cell-depleting therapies
Key Trial Info
Start Date :
March 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01000610
Start Date
March 17 2008
End Date
May 16 2012
Last Update
August 16 2017
Active Locations (4)
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1
Hopital Farhat Hached; Service Rhumatologie
Sousse, Tunisia, 4000
2
Hopital Charles Nicole; Service Rhumatologie
Tunis, Tunisia, 1006
3
Hopital La Rabta; Service Rhumatologie
Tunis, Tunisia, 1007
4
Hopital Mongi Slim; Service Rhumatologie
Tunis, Tunisia, 2046