Skip to main content
OpenTrials
Completed

NCT Number: NCT00144625

Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polyarticular 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

  • Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
  • the patients who did not have problems with safety in the previous study"

Exclusion criteria

  • Patients who were not enrolled by 3 months after completion of the previous study
  • Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
  • DMARDs or immunosuppressants
  • Intravenous and intramuscular injection of corticosteroids
  • Plasma exchange therapy
  • Other drugs and therapies that may affect evaluation of drug efficacy

Treatment and study plan

MRA(Tocilizumab)

Drug

8mg/kg/4weeks

Primary outcomes

  1. Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS

    Time frame: every 3 months

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

    Time frame: whole period

  3. Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS

    Time frame: every 3 months

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, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

Important dates

Study start
2005
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.