Phase
Condition
White Cell Disorders
Soft Tissue Infections
Skin Wounds
Treatment
N/AClinical Study ID
Ages > 3 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female patients at least 3 years of age
Diagnosis of Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome orNeonatal Onset Multisystem Inflammatory Disease. Prior agreement between theInvestigator and Novartis for study eligibility is required for patients who do nothave a molecular diagnosis of NALP3 mutations available (either testing not performed,or testing performed but negative)upon study entry. For those patients who have notbeen molecularly tested for NALP3 mutations, molecular testing should be performedduring the course of the study
For patients under anakinra therapy or any other investigational IL-1 blockingtherapy, these treatments should be discontinued prior to the baseline visit.
Patients from the CACZ885A2102 study may enter this study. However, dosing at Visit 2 (Baseline Visit) can only occur if either 1) the patient is experiencing disease flareor 2) at least two months have elapsed from their last injection even in the absenceof flare, whichever is earlier.
Patients who completed the CACZ885D2304 study may enter this study
Patients who completed the CACZ885D2201 study may enter this study
Patients who discontinued from the CACZ885A2102, CACZ885D2201 or CACZ885D2304 studiesand for whom in the Investigator's judgment (with prior agreement from Novartis)continued treatment with ACZ885 in this study is considered appropriate.
Exclusion
Exclusion Criteria:
Participation in any clinical investigation within 4 weeks prior to dosing or longerif required by local regulation with the exception of trials with anakinra, otherinvestigational IL-1 blocking therapies, and/or ACZ885.
History of being immunocompromised, including a positive HIV at screening (ELISA andWestern blot) test result.
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result isnot allowed.
No live vaccinations within 3 months prior to the start of the trial, during thetrial, and up to 3 months following the last dose.
History of recurrent and/or evidence of active bacterial, fungal, or viral infections.
Positive tuberculin skin test reaction (PPD 5 tuberculin units or as according tolocal standard practice) (>= 5 mm induration) at 48 to 72 hours after administrationat the screening visit or within 2 months prior to the screening visit. Patients whohave a positive PPD skin test with a documentation of BCG vaccination, who are at lowenvironmental risk for tuberculosis (TB) infection or reactivation, and have anegative chest X-ray can be included. Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Novartis Investigative Site
Laeken,
BelgiumSite Not Available
Novartis Investigative Site
Le Kremlin Bicetre,
FranceSite Not Available
Novartis Investigative Site
Lille Cedex,
FranceSite Not Available
Novartis Investigative Site
Montpelier Cedex,
FranceSite Not Available
Novartis Investigative site
Nantes,
FranceSite Not Available
Novartis Investigative site
Berlin,
GermanySite Not Available
Novartis Investigative Site
Hamburg,
GermanySite Not Available
Novartis Investigative site
Heidelburg,
GermanySite Not Available
Novartis Investigative Site
Herne,
GermanySite Not Available
Novartis Investigative Site
Marburg,
GermanySite Not Available
Novartis Investigative site
Tubingen,
GermanySite Not Available
Novartis Investigative site
New Delhi,
IndiaSite Not Available
Novartis Investigative site
Genova,
ItalySite Not Available
Novartis Investigative Site
Napoli,
ItalySite Not Available
Novartis Investigative Site
Padova,
ItalySite Not Available
Novartis Investigative Site
Rome,
ItalySite Not Available
Novartis Investigative Site
Trieste,
ItalySite Not Available
Novartis Investigative Site
Madrid,
SpainSite Not Available
Novartis Investigative site
Oviedo,
SpainSite Not Available
Novartis Investigative Site
Vigo,
SpainSite Not Available
Novartis Investigative site
Istanbul,
TurkeySite Not Available
Novartis Investigative site
London,
United KingdomSite Not Available
Little Rock Allergy and Asthma Clinic
Little Rock, Arkansas 72205
United StatesSite Not Available
UCSF School of Medicine
San Francisco, California 94118
United StatesSite Not Available
Allergy Center at Brookstone
Columbus, Georgia 31904
United StatesSite Not Available
Rush-Presbyterian St. Lukes Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
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