Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) - Full Text View

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 III

MedlinePlus related topics:

Juvenile Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

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
1: Experimental MRA(Tocilizumab)	Drug: MRA(Tocilizumab)

Eligibility

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

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA318JP
First Received:	September 2, 2005
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00144664
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Autoimmune Diseases

Arthritis, Juvenile Rheumatoid

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144664