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

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00144625

Purpose

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

Condition	Intervention	Phase
Polyarticular 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, Extension, Phase III Study to Evaluate the Long-Term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS [ Time Frame: every 3 months ] [ 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 values for the serum MRA concentration [ Time Frame: whole period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	February 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MRA(Tocilizumab) 8mg/kg/4weeks

Eligibility

Ages Eligible for Study:	2 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
the patients who did not have problems with safety in the previous study"

Exclusion criteria

Patients who were not enrolled by 3 months after completion of the previous study
Patients who received any of the following since completion of the previous study until initiation of treatment in the present study
1. DMARDs or immunosuppressants
2. Intravenous and intramuscular injection of corticosteroids
3. Plasma exchange therapy
4. Other drugs and therapies that may affect evaluation of drug efficacy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144625

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director:

Takahiro Kakehi

Chugai Pharmaceutical

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	MRA319JP
Study First Received:	September 2, 2005
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00144625
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