Status:
COMPLETED
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
Lead Sponsor:
Novartis
Conditions:
Muckle Wells Syndrome
Eligibility:
All Genders
4-75 years
Phase:
PHASE3
Brief Summary
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in p...
Eligibility Criteria
Inclusion
- Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-Wells Syndrome.
- Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study, will have the option to participate in this study upon disease flare
- Muckle-Wells Syndrome patients requiring medical intervention either untreated or treated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blocking therapy).
Exclusion
- History of being immunocompromised, including a positive HIV at screening test result.
- No live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
- History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
- History of recurrent and/or evidence of active bacterial, fungal, or viral infections.
- Positive tuberculin skin test at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to national guidelines.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00465985
Start Date
April 1 2007
Last Update
August 28 2017
Active Locations (12)
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1
Novartis Investigative Site
San Francisco, California, United States, 94115
2
Novartis Investigative Site
Chicago, Illinois, United States, 60612
3
Novartis Investigative Site
Madison, Wisconsin, United States, 53792
4
Novartis Investigative Site
Le Kremlin-Bicêtre, France