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NCT00685373 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Cryopyrin-Associated Periodic Syndromes and Familial Cold Autoinflammatory Syndrome, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT00685373: Completed Phase 3 study of Cryopyrin-Associated Periodic Syndromes and Familial Cold Autoinflammatory Syndrome, sponsored by Novartis.
NCT00685373 is a Phase 3 study of Cryopyrin-Associated Periodic Syndromes and Familial Cold Autoinflammatory Syndrome that has completed, run by Novartis. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00685373, a Phase 3 study of Cryopyrin-Associated Periodic Syndromes and Familial Cold Autoinflammatory Syndrome, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The number of participants with Adverse Events and Infections \& Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions
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 |
What the finished NCT00685373 record still lists
NCT00685373 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
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.
NCT00685373 names 20 study sites across 7 states, led by Other, Arkansas, California.
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.
What interventions are being tested in trial NCT00685373?
The interventions under investigation include: Canakinumab (ACZ885) (DRUG).
Who is sponsoring clinical trial NCT00685373?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00685373's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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