Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
December 21, 2009 updated by: Chugai Pharmaceutical
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
8mg/kg/2weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
whole period
|
|
Safety:Incidence and severity of adverse events and adverse reactions
Time Frame: whole period
|
whole period
|
|
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
Time Frame: 0 week and every 2 weeks
|
0 week and every 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
0 week and every 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
December 23, 2009
Last Update Submitted That Met QC Criteria
December 21, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRA317JP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.