Status:
COMPLETED
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving metho...
Eligibility Criteria
Inclusion
- adult patients, ≥ 18 years of age;
- moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) \> 4.4);
- inadequate response to methotrexate;
- on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.
Exclusion
- prior treatment with a biologic;
- Rheumatoid arthritis (RA) functional class IV;
- known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
- evidence of active malignant disease.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT00810199
Start Date
March 1 2009
End Date
January 1 2013
Last Update
July 18 2014
Active Locations (137)
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1
Santa Monica, California, United States, 90404
2
Upland, California, United States, 91786
3
Whittier, California, United States, 90606
4
Aventura, Florida, United States, 33180