Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144612
• Other study ID #: MRA317JP
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: December 21, 2009
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• 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

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 19 Years

Eligibility

Inclusion criteria (MRA011JP patients)

• Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period

• the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)

• Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal

• Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

• Patients who were not enrolled by 3 months after completion of the previous study

• Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Systemic Juvenile Idiopathic Arthritis

Intervention

Drug:
• MRA(Tocilizumab)
8mg/kg/2weeks

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 compared with before the first infusion of the investigational product (including the previous study)		whole period	No
Primary	Safety:Incidence and severity of adverse events and adverse reactions		whole period	Yes
Primary	Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks		0 week and every 2 weeks	No
Secondary	Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks		0 week and every 2 weeks	No