Clinical trial
An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan
NCT00991146 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- An Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1β Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in Japan
- Lead sponsor
- Novartis Pharmaceuticals
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- October 31, 2009
- Completion date
- February 29, 2012
- Enrollment
- 19 (actual)
- Sites
- 3
Conditions
As the registry lists them; a condition with its own page is linked.
cryopyrin-associated periodic syndromes, familial cold autoinflammatory syndrome, muckle-wells syndrome, neonatal onset multisystem inflammatory disease