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

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ClinicalTrials.gov Identifier: NCT00144612

Recruitment Status : Completed

First Posted : September 5, 2005

Last Update Posted : December 23, 2009

Sponsor:

Information provided by:

Chugai Pharmaceutical

Study Description

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

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2004
Actual Primary Completion Date :	June 2005
Actual Study Completion Date :	June 2009

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Juvenile idiopathic arthritis

MedlinePlus related topics: Arthritis Juvenile Arthritis

Genetic and Rare Diseases Information Center resources: Systemic Onset Juvenile Idiopathic Arthritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Drug: MRA(Tocilizumab) 8mg/kg/2weeks

Outcome Measures

Primary Outcome Measures :

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 ]
Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ]
Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ]

Secondary Outcome Measures :

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 ]

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 (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

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): NCT00144612

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators


Study Director:	Takahiro Kakehi	Chugai Pharmaceutical

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aoki C, Inaba Y, Choe H, Kaneko U, Hara R, Miyamae T, Imagawa T, Mori M, Oba MS, Yokota S, Saito T. Discrepancy between clinical and radiological responses to tocilizumab treatment in patients with systemic-onset juvenile idiopathic arthritis. J Rheumatol. 2014 Jun;41(6):1171-7. doi: 10.3899/jrheum.130924. Epub 2014 May 1. Erratum in: J Rheumatol. 2014 Jul;41(7):1567.

Yokota S, Imagawa T, Mori M, Miyamae T, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan. J Rheumatol. 2014 Apr;41(4):759-67. doi: 10.3899/jrheum.130690. Epub 2014 Mar 15.

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. doi: 10.1016/S0140-6736(08)60454-7.


Responsible Party:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144612 History of Changes
Other Study ID Numbers:	MRA317JP
First Posted:	September 5, 2005 Key Record Dates
Last Update Posted:	December 23, 2009
Last Verified:	December 2009

Additional relevant MeSH terms:


Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases	Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

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