Back to resultsStudy of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Primary Purpose
Systemic Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRA(Tocilizumab)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion criteria Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997) Patients between 2 and 19 years of age Patients who are under 16 years of age at onset Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions Exclusion criteria Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product Patients who have received the following treatments within 4 weeks before treatment with the investigational product Surgical treatment (e.g., operation) Plasma exchange therapy"
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
Efficacy:Percentage of patients in whom effects were maintained
Safety:Incidence and severity of adverse events and adverse drug reactions
Pharmacokinetics:The time course of the trough serum MRA concentration
Secondary Outcome Measures
Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00144599
Brief Title
Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Official Title
A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
Time Frame
open-label period
Title
Efficacy:Percentage of patients in whom effects were maintained
Time Frame
Blind period
Title
Safety:Incidence and severity of adverse events and adverse drug reactions
Time Frame
whole period
Title
Pharmacokinetics:The time course of the trough serum MRA concentration
Time Frame
whole period
Secondary Outcome Measure Information:
Title
Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score
Time Frame
Open-label period
Title
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS
Time Frame
Blind Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
Patients between 2 and 19 years of age
Patients who are under 16 years of age at onset
Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions
Exclusion criteria
Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
Patients who have received the following treatments within 4 weeks before treatment with the investigational product
Surgical treatment (e.g., operation)
Plasma exchange therapy"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahiro Kakehi
Organizational Affiliation
Chugai Pharmaceutical
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24786929
Citation
Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T. Discrepancy between clinical and radiological responses to tocilizumab treatment in patients with systemic-onset juvenile idiopathic arthritis. J Rheumatol. 2014 Jun;41(6):1171-7. doi: 10.3899/jrheum.130924. Epub 2014 May 1. Erratum In: J Rheumatol. 2014 Jul;41(7):1567.
Results Reference
derived
PubMed Identifier
24634205
Citation
Yokota S, Imagawa T, Mori M, Miyamae T, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan. J Rheumatol. 2014 Apr;41(4):759-67. doi: 10.3899/jrheum.130690. Epub 2014 Mar 15.
Results Reference
derived
PubMed Identifier
18358927
Citation
Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. doi: 10.1016/S0140-6736(08)60454-7.
Results Reference
derived
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Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
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