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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
6 mL glass vial containing 150 mg lyophilized Canakinumab reconstituted with water for a subcutaneous injection every 8 weeks. Dosage based on body weight.
Little Rock Allergy and Asthma Clinic
Little Rock, Arkansas, United States
UCSF School of Medicine
San Francisco, California, United States
Allergy Center at Brookstone
Columbus, Georgia, United States
Rush-Presbyterian St. Lukes Medical Center
Chicago, Illinois, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Wisconsin
Madison, Wisconsin, United States
Novartis Investigative Site
Laken, Belgium
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Montpelier Cedex, France
...and 18 more locations
The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions
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.
Time frame: 2 years depending on when the participant enters the study
The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers.
Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result \> 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity \> minimal or Physician's Global Assessment \>= minimal AND Skin Disease Assessment \> minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe.
Time frame: Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years
Immunogenicity of Canakinumab (ACZ885)
The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study.
Time frame: Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years
Pharmacokinetics
Mean Clearance from serum in Liter per Day (CLD) in adult participants \>=18, pediatric participants \<18 with body weight \>40 kg and pediatric participants \<18 with body weight \<=40 kg.
Time frame: Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years
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