Status:
COMPLETED
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants 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 randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe ...
Eligibility Criteria
Inclusion
- Adult participants, ≥ 18 years of age
- Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
- Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
- Inadequate response to current DMARD therapy
- Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
- Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
Exclusion
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than RA
- Functional class IV (ACR classification)
- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
- Prior history of or current inflammatory joint disease other than RA
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Previous treatment with tocilizumab
- Active current or history of recurrent infection
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
1262 Patients enrolled
Trial Details
Trial ID
NCT01194414
Start Date
September 1 2010
End Date
August 1 2013
Last Update
June 20 2016
Active Locations (216)
Enter a location and click search to find clinical trials sorted by distance.
1
Huntsville, Alabama, United States, 35801
2
Tuscaloosa, Alabama, United States, 35406
3
Tucson, Arizona, United States, 85704
4
Tucson, Arizona, United States, 85712