CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 166 enrolled
Drug / intervention
Canakinumab (ACZ885)drug
Likely dose
Canakinumab (ACZ885) 6 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00685373
NCT00685373Phase 3Completed
CompareCT.gov

An Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1β Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

Novartis·interventional·Posted May 28, 2008·Updated Nov 4, 2016

In Brief

A Phase 3 clinical trial evaluating Canakinumab (ACZ885) for Cryopyrin-Associated Periodic Syndromes and 3 related conditions. Completed, enrolled 166 participants across 28 sites in 9 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
CountriesBelgium, France, Germany, India, Italy, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2008
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.1 years ago

Interventions

Canakinumab (ACZ885)drug

6 mL glass vial containing 150 mg lyophilized Canakinumab reconstituted with water for a subcutaneous injection every 8 weeks. Dosage based on body weight.