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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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18 April 2012 |
Main ID: |
EUCTR2005-004008-36-IT |
Date of registration:
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30/01/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis
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Scientific title:
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Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis |
Date of first enrolment:
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27/10/2005 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004008-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group: no
Cross over: no
Other:
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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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with CINCA/MUCKLE-WELLS:Patients with CINCA/MUCKLE-WELLS with active disease Patients with systemic juvenile idiopathic arthritis: Patients with systemic juvenile idiopathic arthritis with active disease Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes 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: Treatment with anti-TNF therapy Infections on-going Immunosupressive treatment in six previous weeks
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis MedDRA version: 14.1
Level: SOC
Classification code 10010331
Term: Congenital, familial and genetic disorders
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Trade Name: KINERET*SC 7SIR 100MG 0,67ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Anakinra Concentration unit: mg milligram(s) Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: non applicabile
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Main Objective: Patients with CINCA/MUCKLE-WELLS: will be considered responders to therapy if they present a reduction of at least 70% of systemic symptoms and of inflammatory index versus baseline Patients with systemic juvenile idiopathic arthritis:will be considered responders to therapy if they present a reduction of at least 70% of systemic symptoms and of inflammatory index versus baseline Treatment will be considered effective with a number of responder higher than 50%
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Primary end point(s): Patients with CINCA/MUCKLE-WELLS: will be considered responders to therapy if they present a reduction of at least 70% of systemic symptoms and of inflammatory index versus baseline Patients with systemic juvenile idiopathic arthritis:will be considered responders to therapy if they present a reduction of at least 70% of systemic symptoms and of inflammatory inde xversus baseline
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Source(s) of Monetary Support
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Results
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Results available:
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