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
NCT ID: NCT00977106
Last Updated: 2014-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2009-06-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
single iv infusion 8 mg/kg
2
placebo
single iv infusion
3
tocilizumab [RoActemra/Actemra]
iv infusion 8mg/kg every 4 weeks for 11 months
Interventions
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tocilizumab [RoActemra/Actemra]
single iv infusion 8 mg/kg
placebo
single iv infusion
tocilizumab [RoActemra/Actemra]
iv infusion 8mg/kg every 4 weeks for 11 months
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Amiens, , France
Amiens, , France
Bayonne, , France
Bois-Guillaume, , France
Bordeaux, , France
Brest, , France
Cahors, , France
Chambray-lès-Tours, , France
Clermont-Ferrand, , France
Échirolles, , France
La Roche-sur-Yon, , France
Limoges, , France
Lyon, , France
Metz, , France
Nantes, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Rennes, , France
Saint-Priest-en-Jarez, , France
Toulouse, , France
Countries
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Other Identifiers
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2008-008309-23
Identifier Type: -
Identifier Source: secondary_id
ML22017
Identifier Type: -
Identifier Source: org_study_id
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