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Completed

NCT Number: NCT00144664

Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

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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 who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
  • Patients aged at least 2 years old and less than 20.
  • Patients aged less than 16 years old at time of onset

Exclusion criteria

  • Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product
  • Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product

Treatment and study plan

MRA(Tocilizumab)

Drug

Primary outcomes

  1. Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS

    Time frame: whole period

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

    Time frame: whole period

  3. Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration

    Time frame: whole period

Secondary outcomes

  1. Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS

    Time frame: whole period

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

Important dates

Study start
2004
Primary completion
2005
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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