Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

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Brief Title

Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

Official Title

Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease

Brief Summary

      The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or
      refractory patients diagnosed with active Kawasaki disease, administration of canakinumab
      controls fever and acute phase reactants.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

resolution of fever

Secondary Outcome

 proportion of patients with C-reactive Protein reduction

Condition

Kawasaki Disease

Intervention

Canakinumab

Study Arms / Comparison Groups

 Kawasaki patients
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

November 15, 2016

Completion Date

November 30, 2017

Primary Completion Date

November 30, 2017

Eligibility Criteria

        Key Inclusion Criteria:

        -Active Kawasaki disease defined as:

          -  fever ≥38.5°C for ≥5 days

          -  four out of five of the following criteria: (i) conjunctival injection, (ii) oral
             mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii)
             erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy

        Key Exclusion Criteria:

        Patients fulfilling any of the following criteria are not eligible for inclusion in this
        study:

          -  Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease
             (for IVIG-naïve patients, Cohort 1)

          -  Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve
             patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory
             patients, Cohort 2)

          -  History of hypersensitivity to any of the study drugs or to drugs or similar chemical
             classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate
             dehydrate polysorbate 80; sodium hydroxide; water for injections)

        Other protocol-defined inclusion/exclusion may apply.
      

Gender

All

Ages

N/A - 10 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 



Administrative Informations


NCT ID

NCT02980263

Organization ID

CACZ885D2208


Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

February 2017