Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Systemic Juvenile Idiopathic Arthritis

Treatments: Drug: placebo; Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144599

MRA316JP

Details and patient eligibility

About

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Enrollment: 56 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
• Patients between 2 and 19 years of age
• Patients who are under 16 years of age at onset
• Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

Exclusion criteria

• Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product

• Patients who have received the following treatments within 4 weeks before treatment with the investigational product

  1. Surgical treatment (e.g., operation)
  2. Plasma exchange therapy"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MRA(Tocilizumab)

2

Placebo Comparator group

Treatment:

Drug: placebo