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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00144664
Other study ID # MRA318JP
Secondary ID
Status Completed
Phase Phase 3
First received September 2, 2005
Last updated July 29, 2008
Start date November 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 an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.


Recruitment information / eligibility

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

- Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)

- Patients aged at least 2 years old and less than 20.

- Patients aged less than 16 years old at time of onset

Exclusion criteria

- Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product

- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MRA(Tocilizumab)


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 on LOBS whole period No
Primary Safety:Incidence and severity of adverse events and adverse drug reactions whole period Yes
Primary Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration whole period No
Secondary Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS whole period No
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