Status:
COMPLETED
A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadeq...
Eligibility Criteria
Inclusion
- Moderate to severe active RA of ≥6 months duration
- DAS28 \>3.2
- Inadequate response to a stable dose of non-biologic DMARD for ≥2 months
- Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment
Exclusion
- Rheumatic autoimmune disease other than RA
- History of or current inflammatory joint disease other than RA
- Previous treatment with alkylating agents or total lymphoid irradiation
- Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline
- Previous treatment with any cell-depleting therapies
- American College of Rheumatology (ACR) Functional Class IV
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00996606
Start Date
October 1 2009
End Date
April 1 2012
Last Update
June 19 2017
Active Locations (11)
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1
Coppito, Abruzzo, Italy, 67100
2
Napoli, Campania, Italy, 80131
3
Rome, Lazio, Italy, 00161
4
Genoa, Liguria, Italy, 16132