Clinical Trials Directory

Trials / Completed

CompletedNCT00685373

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
166 (actual)
Sponsor
Novartis · Industry
Sex
All
Age
3 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGCanakinumab (ACZ885)6 mL glass vial containing 150 mg lyophilized Canakinumab reconstituted with water for a subcutaneous injection every 8 weeks. Dosage based on body weight.

Timeline

Start date
2008-05-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2008-05-28
Last updated
2016-11-04
Results posted
2011-05-27

Locations

28 sites across 9 countries: United States, Belgium, France, Germany, India, Italy, Spain, Turkey (Türkiye), United Kingdom

Source: ClinicalTrials.gov record NCT00685373. Inclusion in this directory is not an endorsement.