Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Systemic Juvenile Idiopathic Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144664

MRA318JP

Details and patient eligibility

About

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Enrollment: 19 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

1

Experimental group

Description:

MRA(Tocilizumab)

Treatment:

Drug: MRA(Tocilizumab)