Treatment with Anakinra in TRAPS - ND

• Conditions: TRAPS; MedDRA version: 9.1Level: LLTClassification code 10016202Term: Familial amyloidosis

• Registration Number: EUCTR2006-001927-20-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with molecular diagnosis of TRAPS with

1) more than 2 episodes/year lasting at least one week with limitation of normal daily activities

2) chronic disease course with steroid dependence and/or limitation of normal daily activities

3) Persistently high level of SAA in at least 3 determinations in the presence of 24h proteinuria
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

1.Immunosuppressive treatment in the 6 week before

2. Ongoing infections

3. Positive history for drug-resistent TBC

4. Active TBC

5. Positive PPD test at the time of enrollment

6. Low white cell count (<1.5x106/l) or thrombocytopenia (<150,000/mm3) 7. Liver enzymes 3 times above the normal range

8. Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of 70% of acute phase reactants (ESR, CRP) after 15 days of treatment and after 6 months. Reduction of 70% of global evaluation of disease activity after 15 days of treatment and after 6 months. Reduction of 70% of proteinuria and SAA (in patients with amyloidosis) after 6 months of treatmment.;Secondary Objective: Reduction of global steroid requirement dosage in respect to previous episodes and/or pre-treatment.;Primary end point(s): Reduction of 70% of actute phase reactants (ESR, CRP) after 15 days of treatment and after 6 months. Reduction of 70% of global evaluation of disease activity after 15 days of treatment and after 6 months. Reduction of 70% of proteinuria and SAA (in patients with amyloidosis) after 6 months of treatmment.