Back to resultsLong-term Treatment Study 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)
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion criteria (MRA011JP patients) Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients) Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period Exclusion criteria Patients who were not enrolled by 3 months after completion of the previous study Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
Safety:Incidence and severity of adverse events and adverse reactions
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
Secondary Outcome Measures
Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks
Full Information
NCT ID
NCT00144612
First Posted
September 2, 2005
Last Updated
December 21, 2009
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144612
Brief Title
Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Official Title
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Intervention Description
8mg/kg/2weeks
Primary Outcome Measure Information:
Title
Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
Time Frame
whole period
Title
Safety:Incidence and severity of adverse events and adverse reactions
Time Frame
whole period
Title
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
Time Frame
0 week and every 2 weeks
Secondary Outcome Measure Information:
Title
Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks
Time Frame
0 week and every 2 weeks
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 (MRA011JP patients)
Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period
Exclusion criteria
Patients who were not enrolled by 3 months after completion of the previous study
Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
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
Learn more about this trial
Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
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