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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00144612
Other study ID # MRA317JP
Secondary ID
Status Completed
Phase Phase 3
First received September 2, 2005
Last updated December 21, 2009
Start date July 2004
Est. completion date June 2009

Study information

Verified date December 2009
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

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2009
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 19 Years
Eligibility 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

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)
8mg/kg/2weeks

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 compared with before the first infusion of the investigational product (including the previous study) whole period No
Primary Safety:Incidence and severity of adverse events and adverse reactions whole period Yes
Primary Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks 0 week and every 2 weeks No
Secondary 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 0 week and every 2 weeks No
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