Study:
An Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1ß 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
Rationale:
n/a
Purpose:
This study will provide long-term safety and efficacy data for ACZ885 (a fully human
anti-interleukin-1ß [anti-IL-1ß] 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 is at least 6 months with a maximum duration of 2 years,
depending on when the patient enters the study.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Cryopyrin-associated Periodic Syndromes:
Familial Cold Autoinflammatory Syndrome
Muckle Wells Syndrome
Neonatal Onset Multisystem Inflammatory Disease |
Drug: Canakinumab (ACZ885) |
Phase 3 |
Verified by
Novartis
July, 2012
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov identifier: NCT00685373
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
n/a