Status:
COMPLETED
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-T...
Eligibility Criteria
Inclusion
- adult patients, 18-80 years of age;
- rheumatoid arthritis for \>=6 months;
- receiving outpatient treatment;
- an inadequate response to at least one anti-TNF therapy;
- stable methotrexate for \>=12 weeks.
Exclusion
- other rheumatic autoimmune disease or inflammatory joint disease;
- previous treatment with MabThera;
- concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00462345
Start Date
June 1 2007
End Date
July 1 2009
Last Update
November 4 2014
Active Locations (4)
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1
Seoul, South Korea, 110-744
2
Seoul, South Korea, 133-792
3
Seoul, South Korea, 137701
4
Seoul, South Korea, 138-736