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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00144599
Other study ID # MRA316JP
Secondary ID
Status Completed
Phase Phase 3
First received September 2, 2005
Last updated July 29, 2008
Start date May 2004
Est. completion date October 2005

Study information

Verified date July 2008
Source Chugai Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 19 Years
Eligibility 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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MRA(Tocilizumab)

placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chugai Pharmaceutical

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS open-label period No
Primary Efficacy:Percentage of patients in whom effects were maintained Blind period No
Primary Safety:Incidence and severity of adverse events and adverse drug reactions whole period Yes
Primary Pharmacokinetics:The time course of the trough serum MRA concentration whole period No
Secondary 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 Open-label period No
Secondary 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 Blind Period No
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