Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144625
First received: September 2, 2005
Last updated: December 21, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Polyarticular 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, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

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 every 3M, LOBS [ Time Frame: every 3 months ] [ 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 time course of the trough values for the serum MRA concentration [ Time Frame: whole period ] [ Designated as safety issue: Yes ]

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

Enrollment: 19
Study Start Date: February 2005
Study Completion Date: June 2009
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg/4weeks

  Eligibility

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

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

    1. DMARDs or immunosuppressants
    2. Intravenous and intramuscular injection of corticosteroids
    3. Plasma exchange therapy
    4. Other drugs and therapies that may affect evaluation of drug efficacy
  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: NCT00144625

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144625     History of Changes
Other Study ID Numbers: MRA319JP
Study First Received: September 2, 2005
Last Updated: December 21, 2009
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 November 20, 2014