A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis
NCT ID: NCT01332994
Last Updated: 2015-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
519 participants
INTERVENTIONAL
2011-03-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 12 weeks.
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
2
rituximab [MabThera/Rituxan]
1 g intravenously at Week 16 and 18
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 12 weeks.
Interventions
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rituximab [MabThera/Rituxan]
1 g intravenously at Week 16 and 18
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 12 weeks.
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
Eligibility Criteria
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Inclusion Criteria
* Body weight \< /=130kg
* Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
* Disease Activity Score (DAS28) of \>3.2
* Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
* Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline
Exclusion Criteria
* Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
* Functional class IV (American College of Rheumatology classification)
* Rheumatic autoimmune disease other than rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
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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Aachen, , Germany
Bad Aibling, , Germany
Bad Bramstedt, , Germany
Bad Nauheim, , Germany
Bad Staffelstein, , Germany
Bayreuth, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Blaubeuren Abbey, , Germany
Bonn, , Germany
Bruchhausen-Vilsen, , Germany
Chemnitz, , Germany
Cologne, , Germany
Cologne, , Germany
Cologne, , Germany
Donaueschingen, , Germany
Dresden, , Germany
Dresden, , Germany
Dresden, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Düsseldorf, , Germany
Erfurt, , Germany
Essen, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Giessen, , Germany
Gommern, , Germany
Goslar, , Germany
Göttingen, , Germany
Greifswald, , Germany
Halle, , Germany
Halle, , Germany
Halle, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Heidelberg, , Germany
Herne, , Germany
Hildesheim, , Germany
Hofheim, , Germany
Jena, , Germany
Kiel, , Germany
Leipzig, , Germany
Leipzig, , Germany
Lingen, , Germany
Ludwigsfelde, , Germany
Mainz, , Germany
Mönchengladbach, , Germany
München, , Germany
München, , Germany
München, , Germany
Naumburg, , Germany
Naunhof, , Germany
Neuss, , Germany
Neuss, , Germany
Nienburg, , Germany
Olsberg, , Germany
Osnabrück, , Germany
Plochingen, , Germany
Potsdam, , Germany
Ratingen, , Germany
Regensburg, , Germany
Rendsburg, , Germany
Rheine, , Germany
Rostock, , Germany
Saarbrücken, , Germany
Sendenhorst, , Germany
Stuttgart, , Germany
Stuttgart, , Germany
Traunstein, , Germany
Trier, , Germany
Tübingen, , Germany
Ulm, , Germany
Wiesbaden, , Germany
Würzburg, , Germany
Countries
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Other Identifiers
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ML22985
Identifier Type: -
Identifier Source: org_study_id
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