Status:
COMPLETED
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with mode...
Eligibility Criteria
Inclusion
- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to a stable dose of MTX;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion
- major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study;
- prior treatment failure with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT00106548
End Date
October 1 2007
Last Update
June 11 2010
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
Buenos Aires, Argentina, 1405
2
Buenos Aires, Argentina, C1015ABO
3
Buenos Aires, Argentina, C1428CQG
4
Adelaide, Australia, 5041