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

This study has been completed.
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
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

Condition Intervention Phase
Systemic Juvenile Idiopathic Arthritis
Drug: MRA(Tocilizumab)
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 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) [ Time Frame: whole period ] [ Designated as safety issue: No ]
  • Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: June 2009
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)


Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00144612

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Takahiro Kakehi Chugai Pharmaceutical
  More Information

No publications provided by Chugai Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144612     History of Changes
Other Study ID Numbers: MRA317JP 
Study First Received: September 2, 2005
Last Updated: December 21, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2016