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: |
NCT00144599 |
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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Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
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Scientific title:
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A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA |
Date of first enrolment:
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May 2004 |
Target sample size:
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56 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00144599 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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
- 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
1. Surgical treatment (e.g., operation)
2. Plasma exchange therapy"
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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Drug: placebo
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Primary Outcome(s)
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Safety:Incidence and severity of adverse events and adverse drug reactions
[Time Frame: whole period]
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Pharmacokinetics:The time course of the trough serum MRA concentration
[Time Frame: whole period]
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Efficacy:Percentage of patients in whom effects were maintained
[Time Frame: Blind period]
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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]
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Secondary Outcome(s)
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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]
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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]
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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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