Status:
COMPLETED
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 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, both in combination with DMARDs, in patients with active rheumatoi...
Eligibility Criteria
Inclusion
- adult patients, 18-70 years of age;
- rheumatoid arthritis for \>= 6 months;
- receiving permitted DMARDs, at a stable dose, for \>= 8 weeks prior to baseline;
- current inadequate clinical response to DMARDs.
Exclusion
- major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
- rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- unsuccessful treatment with an anti-TNF agent;
- previous treatment with tocilizumab.
Key Trial Info
Start Date :
October 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2010
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00773461
Start Date
October 31 2008
End Date
July 22 2010
Last Update
August 1 2017
Active Locations (9)
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1
Peking University People's Hospital
Beijing, China, 100044
2
Beijing Union Hospital
Beijing, China, 100730
3
General Hospital of Chinese PLA; Department of Hematology
Beijing, China, 100853
4
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China, 510630