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Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144599
First received: September 2, 2005
Last updated: July 29, 2008
Last verified: July 2008
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

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, Percentage of patients showing improvement in CRP on LOBS [ Time Frame: open-label period ] [ Designated as safety issue: No ]
  • Efficacy:Percentage of patients in whom effects were maintained [ Time Frame: Blind period ] [ Designated as safety issue: No ]
  • Safety:Incidence and severity of adverse events and adverse drug reactions [ Time Frame: whole period ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics:The time course of the trough serum MRA concentration [ Time Frame: whole period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Open-label period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Blind Period ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2004
Study Completion Date: October 2005
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
Placebo Comparator: 2 Drug: placebo

  Eligibility

Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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"
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144599

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: NCT00144599     History of Changes
Other Study ID Numbers: MRA316JP
Study First Received: September 2, 2005
Last Updated: July 29, 2008
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