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Completed

NCT Number: NCT00144599

Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

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

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Key information

Conditions

Systemic Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Surgical treatment (e.g., operation)
  • Plasma exchange therapy"

Treatment and study plan

MRA(Tocilizumab)

Drug

Placebo

Drug

Primary outcomes

  1. 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

  2. Efficacy:Percentage of patients in whom effects were maintained

    Time frame: Blind period

  3. Safety:Incidence and severity of adverse events and adverse drug reactions

    Time frame: whole period

  4. Pharmacokinetics:The time course of the trough serum MRA concentration

    Time frame: whole period

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Important dates

Study start
2004
Study completion
2005
First posted
Sep 5, 2005
Registry last updated
Jul 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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