Status:
COMPLETED
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or par...
Eligibility Criteria
Inclusion
- adult patients \>=18 years of age;
- RA for \>=6 months;
- receiving outpatient treatment;
- inadequate response to methotrexate, having received and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.
Exclusion
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
- inflammatory joint disease other than RA, or other systemic autoimmune disorder;
- diagnosis of juvenile arthritis, or RA before the age of 16;
- previous treatment with \>1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00422383
Start Date
February 1 2006
End Date
March 1 2013
Last Update
May 4 2015
Active Locations (91)
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1
Coffs Harbour, New South Wales, Australia, 2450
2
Sydney, New South Wales, Australia, 2145
3
Maroochydore, Queensland, Australia, 4558
4
Southport, Queensland, Australia, 4215