Status:
TERMINATED
A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) vers...
Eligibility Criteria
Inclusion
- Adult patients, over the age of 18 years
- Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
- DAS28 \>3.2
- Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
- Patients who have received DMARDs (including methotrexate) for 3-7 months
Exclusion
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
- Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
- Prior history of or current inflammatory joint disease other than RA
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01251120
Start Date
November 1 2011
End Date
January 1 2013
Last Update
November 11 2014
Active Locations (6)
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1
Hämeenlinna, Finland, 13530
2
Helsinki, Finland, 00029
3
Jyväskylä, Finland, 40620
4
Kuopio, Finland, 70101