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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144612
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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:

Drug Information available for: Tocilizumab
U.S. FDA Resources

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)
8mg/kg/2weeks

  Eligibility

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

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

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
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
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013