Status:
COMPLETED
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate respo...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- moderate to severe active rheumatoid arthritis for \>6 months;
- inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
- Swollen joint count (SJC) \>/=4 and Tender joint count (TJC) \>/=4
- body weight \</=150kg
- current permitted non-biologic DMARDs must be on stable dose for \>/= 7 weeks prior to baseline;
Exclusion
- history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
- treatment with rituximab within 6 months before screening;
- intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
- known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
886 Patients enrolled
Trial Details
Trial ID
NCT00891020
Start Date
May 1 2009
End Date
March 1 2011
Last Update
October 25 2012
Active Locations (227)
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1
Anniston, Alabama, United States, 36207
2
Birmingham, Alabama, United States, 35205
3
Birmingham, Alabama, United States, 35294
4
Huntsville, Alabama, United States, 35801