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

NCT ID: NCT00144625

Last Updated: 2009-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2009-06-30

Brief 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.

Conditions

Polyarticular Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MRA(Tocilizumab)

Intervention Type: DRUG

8mg/kg/4weeks

Interventions

MRA(Tocilizumab)

8mg/kg/4weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chugai Pharmaceutical

Principal Investigators

Takahiro Kakehi

Role: STUDY_DIRECTOR

Chugai Pharmaceutical

Other Identifiers

MRA319JP

Identifier Type: -

Identifier Source: org_study_id