Status:
COMPLETED
TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or ant...
Eligibility Criteria
Inclusion
- adult patients \>/= 18 years of age
- active moderate or severe rheumatoid arthritis of \<10 years duration with inadequate response to methotrexate or anti-TNF
- on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
- patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks
Exclusion
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- functional class IV by ACR classification
- history of inflammatory joint disease other than RA
- previous treatment with cell-depleting therapies, abatacept or rituximab
- active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics \<4 weeks or oral antibiotics \<2 weeks prior to screening
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00977106
Start Date
June 1 2009
End Date
October 1 2011
Last Update
September 22 2014
Active Locations (22)
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1
Amiens, France, 80054
2
Amiens, France, 80094
3
Bayonne, France, 64109
4
Bois-Guillaume, France, 76233