Trial record 16 of 28 for:    RHEUMATOID ARTHRITIS, SYSTEMIC JUVENILE

Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144664
First received: September 2, 2005
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Systemic Juvenile Idiopathic Arthritis
Drug: MRA(Tocilizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

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 on LOBS [ Time Frame: whole 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 Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration [ Time Frame: whole period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2004
Study Completion Date: October 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MRA(Tocilizumab)
Drug: MRA(Tocilizumab)

  Eligibility

Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144664

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takahiro Kakehi Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144664     History of Changes
Other Study ID Numbers: MRA318JP
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 April 22, 2014