Status:
TERMINATED
A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This single arm study will investigate the pattern of B cell depletion in synovial tissue and peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15) + methotrexat...
Eligibility Criteria
Inclusion
- adult patients 18-80 years of age;
- RA for \>=3 months;
- receiving outpatient treatment;
- failed treatment with \>=1 DMARD (but not anti TNF or other biologic therapy);
- inadequate response to methotrexate, having taken 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;
- history of, or current, inflammatory joint disease other than RA, or other systemic autoimmune disorder;
- diagnosis of RA before the age of 16;
- bone/joint surgery within 12 weeks of study;
- prior use of anti-TNF or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00422942
Start Date
January 1 2006
End Date
June 1 2010
Last Update
July 16 2014
Active Locations (1)
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1
Amsterdam, Netherlands, 1105 AZ