Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144599
• Other study ID #: MRA316JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: July 29, 2008
• Start date: May 2004
• Est. completion date: October 2005

Study information

• Verified date: July 2008
• 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 a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 19 Years

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Systemic Juvenile Idiopathic Arthritis

Intervention

Drug:
• MRA(Tocilizumab)

• placebo

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, Percentage of patients showing improvement in CRP on LOBS		open-label period	No
Primary	Efficacy:Percentage of patients in whom effects were maintained		Blind period	No
Primary	Safety:Incidence and severity of adverse events and adverse drug reactions		whole period	Yes
Primary	Pharmacokinetics:The time course of the trough serum MRA concentration		whole period	No
Secondary	Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score		Open-label period	No
Secondary	Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS		Blind Period	No