Status:
COMPLETED
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
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 in combination with methotrexate (MTX) in patients with moderate to...
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 current anti-rheumatic therapies, including MTX;
- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
- on stable MTX for at least 8 weeks before entering study;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion
- major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
- women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
499 Patients enrolled
Trial Details
Trial ID
NCT00106522
Start Date
May 1 2005
End Date
November 1 2007
Last Update
November 2 2016
Active Locations (168)
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1
Birmingham, Alabama, United States, 35294
2
Huntsville, Alabama, United States, 35801
3
Scottsdale, Arizona, United States, 85251
4
Scottsdale, Arizona, United States, 85258