TRAPS MedDRA version: 9.1 Level: LLT Classification code 10016202 Term: Familial amyloidosis
Conditions
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 type: equal
Concentration number: 1
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed