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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014