Status:
COMPLETED
A Study to Assess the Effect of Tocilizumab + DMARD Therapy 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 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Dr...
Eligibility Criteria
Inclusion
- 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 1 or more traditional DMARDs;
- stable DMARD therapy 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 entering study, or planned surgery within 6 months after entering study;
- patients who have previously failed treatment with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1220 Patients enrolled
Trial Details
Trial ID
NCT00106574
Start Date
April 1 2005
End Date
December 1 2007
Last Update
November 2 2016
Active Locations (146)
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1
Mesa, Arizona, United States, 85208
2
Paradise Valley, Arizona, United States, 85253
3
Peoria, Arizona, United States, 85381
4
Scottsdale, Arizona, United States, 85258