Recent findings suggest that recurrent pericarditis (RP) may be a previously unrecognized autoinflammatory disease. The pivotal pathogenic role of interleukin (IL)-1 in RP has been shown by the achievement of complete responses after treatment with the recombinant IL-1-receptor antagonist, anakinra. Anakinra is the recombinant form of IL-1Ra. The proposed study is designed to demonstarate the efficacy of anakinra in RP.
This is a 8-month, multicenter (3 Italian centers), randomized, double-blind, placebo-controlled, multicenter, medication-withdrawal study to evaluate the efficacy, tolerability, and safety of anakinra in adults and children with idiopathic recurrent pericarditis (RP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Internal Medicine Division, OSpedale Papa Giovanni XXIII
Bergamo, Bergamo, Italy
Pediatric Dept. Ospedale Gaslini
Genova, Genova, Italy
Cardiology Dpt, Maria Vittoria Hospital
Torino, Torino, Italy
Recurrence rate
Time to flare in the anakinra and placebo arms
Time frame: 8 months
1. responder status in the open label phase
To assess the responder status in the open label phase at Day 8 and 60 and at the end of the study with the following three criteria all to be met: 1. no or mild pericardial pain (a score ≤2.5 on a 21 circle VAS), AND 2. normal CRP levels (CRP ≤0.5 mg/dL), AND 3. absent or mild (≤10 mm) echocardiographic effusion. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 60 days
2. change over time of the 3 outcome criteria, i.e. pericardial pain, CRP levels, and echocardiographic effusion;
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 8 months
3. time to response in the open label phase
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 8 months
4. percentage of patients who relapse in the withdrawal part in the two arms;
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 8 months
5. change over time in patient's/parent's global assessment of overall well being on a 21 circle VAS;
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
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Time frame: 8 months
6. change over time in the global evaluation of disease activity by physicians on a 21 circle VAS
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 8 months
8. percentage off CS and any other concurrent medication at 6weeks
Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 6 weeks
9. tolerability and safety of the treatment
To assess the tolerability and safety of the treatment, i.e. monitoring and recording all adverse events (AEs), with attention to local tolerability to s.c. injection, and serious adverse events (SAEs), and the regularly scheduled monitoring of hematology, blood chemistry, physical examinations, and vital signs including blood pressure over 8 months. Assessments will be performed at Days 4, and 8 (study Period 1), and then at Day 30, and Months 2, 4, 6, and 8 if not otherwise specified.
Time frame: 8 months