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

NCT01302860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-03-29

Study results available
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Summary

This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)

Conditions

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

Interventions

DRUG

ACZ885

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Belgium
  • Canada
  • France
  • Germany
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302860 on ClinicalTrials.gov