Status:
COMPLETED
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and 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 single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with ...
Eligibility Criteria
Inclusion
- patients \>=18 years with moderate to severe active RA for at least 6 months;
- swollen joint count \>=6 (66 joint count) and tender joint count \>=8 (68 joint count) at screening;
- inadequate response to stable dose of MTX;
- patients of reproductive potential must be using a reliable means of contraception.
Exclusion
- rheumatic autoimmune disease other than RA;
- patients with functional class IV RA;
- diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
- prior treatment failure with anti-tumor necrosis factor agent;
- pregnant or breastfeeding women.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00754572
Start Date
February 1 2009
End Date
October 1 2012
Last Update
May 15 2015
Active Locations (69)
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1
Buenos Aires, Argentina, C1280AEB
2
Buenos Aires, Argentina, C1425ASQ
3
Buenos Aires, Argentina, C1426AAL
4
Córdoba, Argentina, X5000FAL