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A One-year Open-label, Multicenter Trial to Assess Efficacy, Safety and Tolerability of Canakinumab (ACZ885) and the Efficacy and Safety of Childhood Vaccinations in Patients Aged 4 Years or Younger With Cryopyrin Associated Periodic Syndromes (CAPS)

This study is currently Recruiting

February 2011 By Novartis

First Recieved on February 22, 2011

Last Updated on February 22, 2011

Sponsor: Novartis Pharmaceuticals
Collaborators:
Information provided by: Novartis
Identifier: NCT01302860

Purpose

This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:N/A
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Male and female patients that are 28 days up to 60 months of age at the time of the screening visit. 2. Body weight > or = 2.5 kg. 3. Parent or legal guardian's written informed consent is required before any assessment is performed for patients. 4. At study entry, patients should have a clinical diagnosis of FCAS, MWS, or NOMID and symptoms requiring pharmacological intervention. Prior agreement between the Investigator and Novartis for study eligibility is required for patients who do not have a molecular diagnosis of NALP3 mutations available (either testing not performed, or testing performed but negative) upon study entry. For those patients who have not been molecularly tested for NALP3 mutations, molecular testing should be performed during the course of the study. 5. For patients treated with an IL-1 blocking agent (i.e. anakinra, rilonacept), these treatments should be discontinued prior to the baseline visit and patients must demonstrate active disease prior to treatment. 6. Patients who are scheduled to receive an immunization, according to their local vaccination guidelines, with an inactivated vaccine must be willing to participate in the assessment schedule for vaccinated patients. Exclusion Criteria: 1. Preterm neonates for whom, in the Investigator's judgment, participation in the study is not deemed appropriate. 2. History of recurrent and/or evidence of active bacterial, fungal, or viral infections (including HIV). 3. Patients with immunodeficiency or treatment with immunosuppressive drugs. 4. Live vaccinations within < or = 3 months prior to screening. No live vaccinations will be allowed throughout the course of this study and up to 3 months following the last dose. 5. Patients with an increased risk of tuberculosis (TB) infection according to following risk factors: - Patients with recent close contact with persons known to have active pulmonary TB disease - Foreign-born patients from countries with a high prevalence of tuberculosis - Patients with recent tuberculosis infection (including children > 6 months with a positive PPD test [defined as an induration of at least 10mm]) - Patients with end-stage renal disease - Patients with diabetes mellitus - Patients receiving immunosuppressive therapy - Patients with hematologic cancers. 6. Participation in another trial within the last 30 days or 5 half-lives of the investigational compound (whichever is longer). 7. Familial and social conditions rendering regular medical assessment not possible. 8. Pediatric patients with neutropenia (absolute neutrophil count [ANC] < 1.5 x 10 to the 9th/l) Other protocol defined inclusion/exclusion criteria may apply

Investigators

  • Investigator: Novartis Pharmaceuticals - Study Director - Novartis Pharmaceuticals

Locations

  • Novartis Investigative site

    Bruxelles, Belgium

  • Novartis Investigative site

    Laeken, Belgium

  • Novartis Investigative site

    Toronto, Canada

  • Novartis Investigative site

    Le Kremlin-Bicetre, France

  • Novartis Investigative site

    Paris, France

  • Novartis Investigative site

    Dresden, Germany

  • Novartis Investigative site

    Sankt Augustin, Germany

  • Novartis Investigative site

    Tubingen, Germany

  • Novartis Investigative site

    Campanar, Spain

  • Novartis Investigative site

    Oloriz, Spain

  • Novartis Investigative site

    Liverpool, United Kingdom

  • Novartis Investigative site

    London, United Kingdom

Conditions related to this trial:

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