A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
NCT ID: NCT01010503
Last Updated: 2014-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2009-06-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg/kg intravenous infusion once in 4 weeks
Interventions
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tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg/kg intravenous infusion once in 4 weeks
Eligibility Criteria
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Inclusion Criteria
* moderate to severe active rheumatoid arthritis
* inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
* DAS \>3.6
* pneumology examination (including chest x-ray and quantiferon)
Exclusion Criteria
* active infection
* active tuberculosis
* uncontrolled hyperlipoproteinaemia
* demyelinating disorders
* concomitant anti-TNF drugs
* history of intestinal ulceration and diverticulitis
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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Piešťany, , Slovakia
Countries
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Other Identifiers
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2009-011520-53
Identifier Type: -
Identifier Source: secondary_id
ML22508
Identifier Type: -
Identifier Source: org_study_id
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