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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00144625
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : December 23, 2009
Information provided by:
Chugai Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment Phase
Polyarticular Juvenile Idiopathic Arthritis Drug: MRA(Tocilizumab) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2005
Primary Completion Date : July 2005
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: MRA(Tocilizumab)

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144625

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Takahiro Kakehi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144625     History of Changes
Other Study ID Numbers: MRA319JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases