Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144664
• Other study ID #: MRA318JP
• 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

• Arthritis
• Arthritis, Juvenile
• Systemic Juvenile Idiopathic Arthritis

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