Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Primary Purpose
Polyarticular Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MRA(Tocilizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Polyarticular Juvenile Idiopathic Arthritis
Eligibility 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 DMARDs or immunosuppressants Intravenous and intramuscular injection of corticosteroids Plasma exchange therapy Other drugs and therapies that may affect evaluation of drug efficacy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Safety:Incidence and severity of adverse events and adverse drug reactions
Pharmacokinetics:The time course of the trough values for the serum MRA concentration
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
Full Information
NCT ID
NCT00144625
First Posted
September 2, 2005
Last Updated
December 21, 2009
Sponsor
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00144625
Brief Title
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyarticular Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MRA(Tocilizumab)
Intervention Description
8mg/kg/4weeks
Primary Outcome Measure Information:
Title
Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Time Frame
every 3 months
Title
Safety:Incidence and severity of adverse events and adverse drug reactions
Time Frame
whole period
Title
Pharmacokinetics:The time course of the trough values for the serum MRA concentration
Time Frame
whole period
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
DMARDs or immunosuppressants
Intravenous and intramuscular injection of corticosteroids
Plasma exchange therapy
Other drugs and therapies that may affect evaluation of drug efficacy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahiro Kakehi
Organizational Affiliation
Chugai Pharmaceutical
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
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