Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00144664 |
Date of registration:
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02/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
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Scientific title:
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An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA |
Date of first enrolment:
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November 2004 |
Target sample size:
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19 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00144664 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Takahiro Kakehi |
Address:
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Telephone:
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Email:
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Affiliation:
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Chugai Pharmaceutical |
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Key inclusion & exclusion criteria
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Inclusion criteria
- Patients who are diagnosed with rheumatoid factor (RF) positive or negative
polyarthritic or oligoarthritic JIA according to the ILAR standards (1997)
- Patients aged at least 2 years old and less than 20.
- Patients aged less than 16 years old at time of onset
Exclusion criteria
- Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks
before initiation of treatment with the investigational product
- Patients who have been treated for the underlying disease with a biological agent,
such as infliximab or etanercept, within 12 weeks before initiation of treatment with
the investigational product
Age minimum:
2 Years
Age maximum:
19 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: MRA(Tocilizumab)
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Primary Outcome(s)
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Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration
[Time Frame: whole period]
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Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
[Time Frame: whole period]
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Safety:Incidence and severity of adverse events and adverse drug reactions
[Time Frame: whole period]
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Secondary Outcome(s)
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Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS
[Time Frame: whole period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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