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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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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-000089-35-IT |
Date of registration:
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30/08/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND
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Scientific title:
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Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND |
Date of first enrolment:
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17/08/2006 |
Target sample size:
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16 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000089-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria: - established diagnosis of Systemic Onset Juvenile Idiopathic Arthritis SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents. - active disease for at least one month prior to enrolment - age at enrolment between 2 and 25 years - age at first SOJIA diagnosis 16 years - reviously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient s enrolment - previously introduced methotrexate treatment for at least three months, without satisfactory results on disease activity or with drug intolerability; and concomitant methotrexate, if any, on a stable dose 61619; 10 mg/m2 weekly for at least four weeks before patient s enrolment - concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient s enrolment Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: - any active infection irrespective of its severity - history of macrophage activation syndrome - clinically significant illness - psychiatric illness - congenital heart and/or central nervous system disorders - inherited metabolic diseases - HIV infection or active hepatitis B and/or C
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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systemic onset juvenile idiopathic arthritis Level: PT
Classification code 10059177
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Intervention(s)
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Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5-
Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-
Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5-
Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-
Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Code: ITF2357 Pharmaceutical Form: Capsule, hard Current Sponsor code: ITF2357 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Primary end point(s): Percentage of patients completing 12 weeks of treatment
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Secondary Objective: 1 to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA 2 to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment 3 to assess the effect of ITF2357 on levels of circulating cytokines 4 to assess pharmacokinetic properties of ITF2357
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Main Objective: To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents
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Secondary ID(s)
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DSC/05/2357/19
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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