Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144599

Purpose

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Condition	Intervention	Phase
Systemic Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab) Drug: placebo	Phase III

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS [ Time Frame: open-label period ] [ Designated as safety issue: No ]
Efficacy:Percentage of patients in whom effects were maintained [ Time Frame: Blind 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 time course of the trough serum MRA concentration [ Time Frame: whole period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score [ Time Frame: Open-label period ] [ Designated as safety issue: No ]
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS [ Time Frame: Blind Period ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
1: Experimental	Drug: MRA(Tocilizumab)
2: Placebo Comparator	Drug: placebo

Eligibility

Criteria

Inclusion criteria

Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
Patients between 2 and 19 years of age
Patients who are under 16 years of age at onset
Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

Exclusion criteria

Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
Patients who have received the following treatments within 4 weeks before treatment with the investigational product
1. Surgical treatment (e.g., operation)
2. Plasma exchange therapy"

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144599

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Publications indexed to this study:

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA316JP
Study First Received:	September 2, 2005
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00144599
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 January 16, 2009