Status:
COMPLETED
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizuma...
Eligibility Criteria
Inclusion
- adult patients at least 18 years of age with active RA for at least 3 months;
- 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 major surgery within 6 months after entering study;
- treatment with methotrexate (MTX) within 6 months of entering study;
- patients who have stopped previous MTX treatment due to toxicity or lack of response;
- women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
673 Patients enrolled
Trial Details
Trial ID
NCT00109408
Start Date
July 1 2005
End Date
December 1 2007
Last Update
November 2 2016
Active Locations (147)
Enter a location and click search to find clinical trials sorted by distance.
1
Montgomery, Alabama, United States, 36111
2
Mesa, Arizona, United States, 85208
3
Paradise Valley, Arizona, United States, 85253
4
Phoenix, Arizona, United States, 85013