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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

3 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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

Key Dates

Start date

May 31, 2008

Status verified

Sep 2016

Primary completion

Apr 30, 2010

Completion

Apr 30, 2010

Study Design

Enrollment

166 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab (ACZ885)
  Subcutaneous injection every 8 weeks based on participant's body weight. Body weight \>40 kilogram (kg): 150 milligrams (mg) per injection and body weight \<= 40 kg: 2 mg/kg per injection. For participants who did not experience sufficient symptomatic relief, an up-titration to the dose and/or more frequent doses were permitted as per protocol.

Primary Outcome Measure

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 [ Time Frame: 2 years depending on when the participant enters the study ]

Locations (6)

Find similar trials in Little Rock, AR

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