A Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
Tracking InformationStart Date ICMJE | |
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Primary Completion Date | |
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Current Primary Outcome Measures ICMJE (submitted: October 1, 2009) | Proportion of patients with a JIA ACR30 flare in Part II (tocilizumab versus placebo) [ Time Frame: weeks 16-40 ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00988221 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: October 1, 2009) | - Efficacy Part I: JIA ACR Core Set Variables [ Time Frame: assessed at weeks 2,4,8,12 and 16 ] [ Designated as safety issue: No ]
- Long-term effect and maintenance of clinical response (Part III): JIA ACR Core Set Variables [ Time Frame: assessed every 4 weeks up to week 104 ] [ Designated as safety issue: No ]
- Safety and tolerability: AEs, laboratory parameters [ Time Frame: throughout study, laboratory assessments every 4 weeks ] [ Designated as safety issue: No ]
- efficacy/safety of 8mg/kg versus 10mg/kg in patients <30kg (Part I, II and III) [ Time Frame: throughout study, clinical and laboratory assessments every 4 weeks ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE | Same as current |
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Descriptive InformationBrief Title ICMJE | A Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis |
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Official Title ICMJE | A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis. |
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Brief Summary | This 3-part study will evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study all patients will receive iv infusions of tocilizumab (8mg/kg for patients >/=30kg, 8mg/kg or 10mg/kg for patients <30kg) every 4 weeks for 16 weeks. For Part II, patients with an adequate response in Part I will be randomized to receive either tocilizumab at the same dose as in Part I or placebo, every 4 weeks for up to 24 weeks. In Part III of the study patients will receive tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without NSAIDs, corticosteroids or methotrexate will continue throughout the study. Anticipated time on study treatment is 2 years, and target sample size is 150-200 individuals. |
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Detailed Description | |
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Study Phase | Phase III |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | Juvenile Idiopathic Arthritis |
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Intervention ICMJE | - Drug: tocilizumab
8mg/kg or 10mg/kg iv infusion every 4 weeks, 16 weeks - Drug: tocilizumab
8mg/kg or 10mg/kg iv infusion every 4 weeks, 24 weeks - Drug: tocilizumab
8mg/kg or 10 mg/kg iv infusion every 4 weeks, 64 weeks - Drug: placebo
iv infusion every 4 weeks, 24 weeks - Drug: NSAIDs, corticosteroids, methotrexate
as prescribed
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Study Arms / Comparison Groups | - I: Active Comparator
Interventions: - Drug: tocilizumab
- Drug: NSAIDs, corticosteroids, methotrexate
- IIA: Experimental
Interventions: - Drug: tocilizumab
- Drug: NSAIDs, corticosteroids, methotrexate
- IIB: Placebo Comparator
Interventions: - Drug: placebo
- Drug: NSAIDs, corticosteroids, methotrexate
- III: Active Comparator
Interventions: - Drug: tocilizumab
- Drug: NSAIDs, corticosteroids, methotrexate
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Recruitment InformationEstimated Enrollment ICMJE | 185 |
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Estimated Completion Date | January 2014 |
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Primary Completion Date | |
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Eligibility Criteria ICMJE | Inclusion Criteria: - children/juveniles, 2-17 years of age
- polyarticular-course juvenile idiopathic arthritis (pcJIA) >/=6 months duration
- active disease (>/=5 active joints, >/=3 with limitation of motion)
- inadequate response to or inability to tolerate methotrexate
- methotrexate, oral corticosteroids and NSAIDs at stable dose(at least 8,4 and 2 weeks,respectively) prior to baseline
- biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic
Exclusion Criteria: - auto-immune, rheumatic disease or overlap syndrome other than polyarticular-course JIA
- wheelchair bound or bedridden
- intraarticular, intramuscular, intravenous or long-acting corticosteroids within 4 weeks prior to baseline
- DMARDs (other than methotrexate) within 4 weeks prior to baseline
- previous treatment with tocilizumab
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Gender | Both |
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Ages | 2 Years to 17 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, United Kingdom |
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Administrative InformationNCT ID ICMJE | NCT00988221 |
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Responsible Party | Disclosures Group, Hoffmann-La Roche |
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Study ID Numbers ICMJE | WA19977, 2009-011593-15 |
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Study Sponsor ICMJE | Hoffmann-La Roche |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Clinical Trials | Hoffmann-La Roche | |
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Information Provided By | Hoffmann-La Roche |
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