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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 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. The trial reports 20 study locations across 7 states.

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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

Conditions Studied

Cryopyrin-Associated Periodic Syndromes Familial Cold Autoinflammatory Syndrome Muckle Wells Syndrome Neonatal Onset Multisystem Inflammatory Disease

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

FieldValue
Enrollment Target 166 participants
Start Date 2008-05
Est. Completion 2010-04
Phase Phase 3

Sponsor

Novartis

265 total trials

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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, categorized as Phase 3. 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 265 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.