KAWAKINRA study, A phase IIa multicenter trial to assess the efficacy and safety of Anakinra in patients with intraveinous immunoglobulin-resistant Kawasaki disease

• 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; MedDRA version: 17.1Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002715-41-ES
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-27
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.Patient, male and female, ? 8 months of life and ? 18 years old,

2.Patient ? 10 kg

3.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 day of fever) and ? 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical criteria and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter ? 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography). For indicative purpose, in case of incomplete KD, other biological supportive criteria for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia.

4.Patient who failed to respond to standard therapy of KD: e.g. Persistence or recrudescence of fever ? 38°C, 48 hours after the infusion of 2g/kg of IV Ig, The interval may be reduced to 24h after the end of the infusion if the patient is still febrile 24h after the end of the infusion.

5.Patient, parents or legal guardian?s written informed consent is required

6.Patient with health insurance

7.Patient agrees to have effective contraception for the duration of participation in the research
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
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

1.Preterm and neonates, pregnancy (+?-hCG if appropriate)

2.Patients suspected with another diagnosis

3.Patients with overt concomitant bacterial infection

4.Patients previously treated with steroids or/and another biotherapy

5.Patients with any type of immunodeficiency or cancer

6.Patients with increased risk of Tuberculosis (TB) infection

7.Recent tuberculosis infection or with active TB

8.Close contact with a patient with TB

9.Patients recently arrived less than 3 months from a country with high prevalence of TB

10. A chest radiograph suggestive of TB

11. Patients with end stage renal disease: NKF stages ?4; eGFR?29mL/min/1.73 m2 or diabetes mellitus or neutropenia <1500/mm3 or liver failure

12.Hypersensitivity to the active substance or to any of the excipients (citric acid and anhydrous; sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)

13.Patient already included in a biomedical research other than observational (e.g.; cohort, registry)

Study & Design

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