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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: EUCTR
Last refreshed on: 18 April 2012
Main ID:  EUCTR2005-004008-36-IT
Date of registration: 30/01/2012
Prospective Registration: No
Primary sponsor: ISTITUTO GIANNINA GASLINI
Public title: Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis
Scientific title: Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis
Date of first enrolment: 27/10/2005
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004008-36
Study type:  Interventional clinical trial of medicinal product
Study design:  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:  
Phase: 
Countries of recruitment
Italy
Contacts
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Affiliation: 
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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
Intervention(s)

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-

Primary Outcome(s)
Secondary Objective: non applicabile
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%
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
Secondary Outcome(s)
Secondary ID(s)
ANAK-01
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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