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

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Polyarticular Juvenile Idiopathic Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144625

MRA319JP

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Treatment:

Drug: MRA(Tocilizumab)