Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biol...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 years of age
- Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration
- Body weight \</=150 kg
- Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment
- Patients with inadequate clinical response to a stable dose of non-biologic DMARD
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 rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01245439
Start Date
September 1 2011
End Date
August 1 2014
Last Update
November 3 2015
Active Locations (17)
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1
Adana, Turkey (Türkiye), 01330
2
Ankara, Turkey (Türkiye), 06100
3
Ankara, Turkey (Türkiye), 06500
4
Aydin, Turkey (Türkiye), 09100