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Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

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ClinicalTrials.gov Identifier: NCT00144664
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : July 30, 2008
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Systemic Juvenile Idiopathic Arthritis Drug: MRA(Tocilizumab) Phase 3

Study Design

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, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA
Study Start Date : November 2004
Primary Completion Date : April 2005
Study Completion Date : October 2005


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS [ Time Frame: whole period ]
  2. Safety:Incidence and severity of adverse events and adverse drug reactions [ Time Frame: whole period ]
  3. Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for 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 evaluation endpoint in the JIA core set, CRP, pain up to LOBS [ Time Frame: whole period ]

Eligibility Criteria

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
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

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): NCT00144664


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

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144664     History of Changes
Other Study ID Numbers: MRA318JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: July 30, 2008
Last Verified: July 2008

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