Status:
COMPLETED
A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With 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 regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoi...
Eligibility Criteria
Inclusion
- adult patients,\>=18 years of age;
- rheumatoid arthritis diagnosed \>8 weeks and \<4 years prior to baseline;
- naive to, or not responding well to, methotrexate;
- swollen joint count \>=8 (66 joint count) and tender joint count\>=8 (68 joint count) at screening and baseline.
Exclusion
- rheumatic autoimmune disease other than rheumatoid arthritis;
- patients with functional class IV rheumatoid arthritis;
- history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
Key Trial Info
Start Date :
December 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00848120
Start Date
December 31 2008
End Date
February 13 2010
Last Update
August 3 2017
Active Locations (4)
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1
Alabang Medical Center
City of Muntinlupa, Philippines, 1770
2
Manila Doctors Hospital; Rheumatology Section
Manila, Philippines, 1000
3
Jose Reyes Memorial Medical Center
Manila, Philippines, 1003
4
Our Lady of Mount Carmel Medical Center
San Fernando City, Philippines, 2000