CompletedPhase 3

Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

Belgium, Canada, France17 participantsStarted 2012-01-16

Plain-language summary

This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study

Who can participate

Age range1 Year – 4 Years

SexALL

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Inclusion criteria

✓. Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
✓. Male and female patients that are ≥ 1 year of age at the time of the roll-over visit.
✓. Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.

Exclusion criteria

✕. Patients for who continued treatment in the CACZ885D2307E1 extension study is not considered appropriate by the treating physician.
✕. Patients who discontinued from the core CACZ885D2307 study

What they're measuring

The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.

Timeframe: Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)

Trial details

NCT IDNCT01576367

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-13

Results submitted2016-06-22

View on ClinicalTrials.gov More Cryopyrin-associated Periodic Syndromes trials