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Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis

Efficacy and safety of treatment with Anakinra in patients with CINCA/MUCKLE-WELLS syndrome and systemic juvenile idiopathic arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004008-36-IT
Enrollment
Unknown
Registered
2012-01-30
Start date
2005-10-27
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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-

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: Treatment with anti-TNF therapy Infections on-going Immunosupressive treatment in six previous weeks

Design outcomes

Primary

MeasureTime frame
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%;Secondary Objective: non applicabile;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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026