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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00144599
Date of registration: 02/09/2005
Prospective Registration: No
Primary sponsor: Chugai Pharmaceutical
Public title: Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Scientific title: A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
Date of first enrolment: May 2004
Target sample size: 56
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00144599
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Contacts
Name:     Takahiro Kakehi
Address: 
Telephone:
Email:
Affiliation:  Chugai Pharmaceutical
Key inclusion & exclusion 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

1. Surgical treatment (e.g., operation)

2. Plasma exchange therapy"



Age minimum: 2 Years
Age maximum: 19 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Systemic Juvenile Idiopathic Arthritis
Intervention(s)
Drug: MRA(Tocilizumab)
Drug: placebo
Primary Outcome(s)
Safety:Incidence and severity of adverse events and adverse drug reactions [Time Frame: whole period]
Pharmacokinetics:The time course of the trough serum MRA concentration [Time Frame: whole period]
Efficacy:Percentage of patients in whom effects were maintained [Time Frame: Blind period]
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]
Secondary Outcome(s)
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]
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]
Secondary ID(s)
MRA316JP
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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