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Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
NCT00685373 · View on ClinicalTrials.gov ↗
Study Summary
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β \[anti-IL-1β\] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease. The duration of this study was 6 months with a maximum duration of 2 years
Conditions Studied
Interventions
- DRUG Canakinumab (ACZ885)
Study Locations (20)
Other
- Novartis Investigative Site — Laken
- Novartis Investigative Site — Le Kremlin-Bicêtre
- Novartis Investigative Site — Lille
- Novartis Investigative Site — Montpelier Cedex
- Novartis Investigative site — Nantes
- Novartis Investigative site — Berlin
- Novartis Investigative Site — Hamburg
- Novartis Investigative site — Heidelberg
- Novartis Investigative Site — Herne
- Novartis Investigative Site — Marburg
- Novartis Investigative site — Tübingen
- Novartis Investigative site — New Delhi
- Novartis Investigative site — Genova
- Novartis Investigative Site — Naples
Arkansas
- Little Rock Allergy and Asthma Clinic — Little Rock
California
- UCSF School of Medicine — San Francisco
Georgia
- Allergy Center at Brookstone — Columbus
Illinois
- Rush-Presbyterian St. Lukes Medical Center — Chicago
Ohio
- Cleveland Clinic — Cleveland
Wisconsin
- University of Wisconsin — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00685373
The ClinicalTrials.gov registry entry for NCT00685373 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Cryopyrin-Associated Periodic Syndromes appearing as the primary indexed condition, and to 1 intervention — of which Canakinumab (ACZ885) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00685373 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00685373 about?
NCT00685373 is a clinical study titled "Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease". This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β \[anti-IL-1β\] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies...
What is the current status of trial NCT00685373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2008-05. Estimated completion is 2010-04.
What conditions does trial NCT00685373 study?
This clinical trial studies the following conditions: Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00685373?
The interventions under investigation include: Canakinumab (ACZ885) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00685373?
This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00685373 being conducted?
This trial has 20 study locations across Arkansas, California, Georgia, Illinois, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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