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Completed

NCT Number: NCT00144612

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

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

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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

(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

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/2weeks

Primary outcomes

  1. 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

  2. Safety:Incidence and severity of adverse events and adverse reactions

    Time frame: whole period

  3. Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks

    Time frame: 0 week and every 2 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2009
First posted
Sep 5, 2005
Registry last updated
Dec 23, 2009

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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