Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00991146
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in Japan. The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to improve signs and symptoms and to prevent secondary disease complications. However, no Japanese patients have been included in those studies. This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen.

Key Dates

Start date
Oct 31, 2009
Status verified
Sep 2020
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: canakinumab

Primary Outcome Measure

Number of participants without a relapse [ Time Frame: 24 weeks ]

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