A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
Tracking Information
Start Date ICMJE | March 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: December 16, 2008) | DAS28 remission rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00810199 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 16, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment |
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Official Title ICMJE | Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients... |
Brief Summary | This 2 arm study will compare 2 treatment strategies based on tocilizumab and/or methotrexate in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a)tocilizumab 8mg iv every 4 weeks + methotrexate po weekly or b)tocilizumab 8mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is 2 years, and the target sample size is 100-500 individuals. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Rheumatoid Arthritis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 470 | ||||
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Estimated Completion Date | February 2012 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Brazil, Croatia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Latvia, Monaco, Netherlands, Norway, Romania, Russian Federation, Serbia, Spain, Sweden, Thailand, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00810199 | ||||
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Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
Study ID Numbers ICMJE | MA21488, 2008-001847-20 | ||||
Study Sponsor ICMJE | Hoffmann-La Roche | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hoffmann-La Roche |
Source: http://clinicaltrials.gov/