Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Polyarticular Juvenile Idiopathic Arthritis Clinical Trial

Official title:

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144625
• Other study ID #: MRA319JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: December 21, 2009
• Start date: February 2005
• 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

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Recruitment information / eligibility

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

Eligibility

Inclusion criteria

• Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted

• the patients who did not have problems with safety in the previous study"

Exclusion criteria

• Patients who were not enrolled by 3 months after completion of the previous study

• Patients who received any of the following since completion of the previous study until initiation of treatment in the present study

1. DMARDs or immunosuppressants

2. Intravenous and intramuscular injection of corticosteroids

3. Plasma exchange therapy

4. Other drugs and therapies that may affect evaluation of drug efficacy

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
• Polyarticular Juvenile Idiopathic Arthritis

Intervention

Drug:
• MRA(Tocilizumab)
8mg/kg/4weeks

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 every 3M, LOBS		every 3 months	No
Primary	Safety:Incidence and severity of adverse events and adverse drug reactions		whole period	Yes
Primary	Pharmacokinetics:The time course of the trough values for the serum MRA concentration		whole period	Yes
Secondary	Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS		every 3 months	No