Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

This study has been completed.

Sponsor:

Information provided by:

Chugai Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00144612

First received: September 2, 2005

Last updated: December 21, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

December 21, 2009

Start Date ^ICMJE

July 2004

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) [ Time Frame: whole period ] [ Designated as safety issue: No ]
Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ] [ Designated as safety issue: Yes ]
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
Incidence and severity of adverse events and adverse reactions
The time profile of the trough serum MRA concentration
Efficacy:
Safety:
Pharmacokinetics:
at 0W, then every 2Wks

Change History

Complete list of historical versions of study NCT00144612 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy:
Time profiles of CRP and ESR, Time profile of percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, Time profiles of JIA core set variables, Time profile of pain, Time profile of corticosteroid dose
at 0W, then every 2Wks

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Official Title ^ICMJE

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP

Brief Summary

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Juvenile Idiopathic Arthritis

Intervention ^ICMJE

Drug: MRA(Tocilizumab)

8mg/kg/2weeks

Study Arm (s)

Experimental: 1

Intervention: Drug: MRA(Tocilizumab)

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria (MRA011JP patients)

Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

Patients who were not enrolled by 3 months after completion of the previous study
Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

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

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00144612

Other Study ID Numbers ^ICMJE

MRA317JP

Has Data Monitoring Committee

Not Provided

Responsible Party

Chugai Pharmaceutical

Study Sponsor ^ICMJE

Chugai Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

Information Provided By

Chugai Pharmaceutical

Verification Date

December 2009

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

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