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

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

July 29, 2008

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP
Percentage of patients in whom effects were maintained
Incidence and severity of adverse events and adverse drug reactions
The time course of the trough serum MRA concentration
Efficacy:
(Open-label period)
on LOBS
(Blind period)
Safety:
Pharmacokinetics:

Change History

Complete list of historical versions of study NCT00144599 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy:
(Open-label period)
Time courses of CRP and ESR, Time course of percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set
(Blind period)
Period for which effects, Time course of CRP and ESR, Time course of percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set

Descriptive Information

Brief Title ^ICMJE

Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Official Title ^ICMJE

A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Systemic Juvenile Idiopathic Arthritis

Intervention ^ICMJE

Drug: MRA(Tocilizumab)
Drug: placebo

Study Arms / Comparison Groups

Publications *

Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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"

Gender

Both

Ages

2 Years to 19 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00144599

Responsible Party

Chugai Pharmaceutical, Chugai Pharmaceutical

Study ID Numbers ^ICMJE

MRA316JP

Study Sponsor ^ICMJE

Chugai Pharmaceutical

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

Information Provided By

Chugai Pharmaceutical

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP