A Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis


Tracking Information

Start Date  ICMJE 
Primary Completion Date 
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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00988221 on ClinicalTrials.gov Archive Site
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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
Official Title  ICMJEA 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.
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEJuvenile Idiopathic Arthritis
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
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

Recruitment Information

Estimated Enrollment  ICMJE185
Estimated Completion DateJanuary 2014
Primary Completion Date 
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
GenderBoth
Ages2 Years to 17 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: WA19977888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00988221
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEWA19977, 2009-011593-15
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche