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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014