Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT00288704
Eligibility Criteria:
Inclusion Criteria:
* Double-blind phases: adults age 18 and above; Open-label extension: Adults and children aged 7 years and older.
* Was diagnosed with Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS) based upon clinical signs and symptoms
* Had documented mutation in NLRP-3 (Cold Induced Autoinflammatory Syndrome-1 or CIAS1) in subject or relative, and willingness to have a confirmatory genetic (Deoxyribonucleic acid or DNA) test (cheek swab).
* Was able to understand and comply with study procedures and was able to provide informed consent
* If female, was not currently pregnant and was willing to use contraception during the study
Exclusion Criteria:
* Had evidence of untreated tuberculosis or other conditions/therapies that made the subject inappropriate for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT00288704
Study Brief:
Protocol Section:
NCT00288704