Essai multicentrique randomisé de phase III comparant l'efficacité et la sécurité de l'anakinra au retraitement par immunoglobulines intraveineuses (IVIG), chez des patients atteints de la maladie de Kawasaki qui n'ont pas répondu au traitement initial standard par IVIG

Phase 1

• Conditions: Anakinra treatment is expected to reduce the early and long-term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003194-22-FR
• Lead Sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-07
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

- Children, male and female, from 3 months to <18 years old
- Patient = 5 kg
- Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever = 5 days (or at least 3 days if KD with AHA criteria since the third days of fever) and = 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter.
- Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever = 38°C, 48 hours after the infusion of 2g/kg of IVIG. Patients may be screened 24h after the end of the first infusion if they remain febrile 24h after the end of the first infusion.
- Patient, parents or legal guardian’s written informed consent is required
- Patient with health insurance (SS or CMU)
Efficient contraception for the duration of participation in the research for childbearing aged women

Are the trial subjects under 18? yes
Number of subjects for this age range: 84
F.1.2 Adults (18-64 years) no
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

- Preterm and neonates, pregnancy and breast feeding
- Suspicion of another diagnosis
- Patient with other concomitant bacterial, viral or fungal infection
- Patient previously treated with steroids and/or another biotherapy
- Patient with increased risk of TB infection
- Recent tuberculosis infection or with active TB
- Patient with any type of immunodeficiency or cancer
- Patients with severe renal impairment (CLcr < 30 ml/minute)
- Patients with hepatic insufficiency
- Patients with neutropenia (ANC<1.5 x109/l)
- Patients included in another interventional protocol
Patient under the following treatments:
- Preventive Antipyretics (paracetamol, NSAIDs other than aspirin 30-50mg/kg given for purpose of KD inflammation)
- Immunosuppressive medications given in a period less than twice of their half-life prior the patient receives the study medication (systemic steroids, cyclosporine, tacrolimus, azathioprine, cyclophosphamide, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF), plasmapheresis)
- Hypersensitivity to anakinra or excipients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide, in water for injection)
- Hypersensitivity to IV Ig, or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies
- Patients with type I or II hyperprolinemia
- Live vaccines within 1 month prior to enrollment
-Hypersensitivity to anakinra or to immunoglobulins or to excipients of Kineret® or Privigen® or to E.coli proteins
- Contraindication for administration of anakinra or IVIG listed in SmPC of Kineret® and Privigen®

Study & Design

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