Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00144612 |
Date of registration:
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02/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
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Scientific title:
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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 |
Date of first enrolment:
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July 2004 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00144612 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Takahiro Kakehi |
Address:
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Telephone:
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Email:
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Affiliation:
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Chugai Pharmaceutical |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
19 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: MRA(Tocilizumab)
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Primary Outcome(s)
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Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks
[Time Frame: 0 week and every 2 weeks]
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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]
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Safety:Incidence and severity of adverse events and adverse reactions
[Time Frame: whole period]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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