Status:
COMPLETED
A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Fibrodysplasia Ossificans Progressiva (FOP)
Eligibility:
All Genders
Brief Summary
Primary Objective(s): * To describe the demographic characteristics of people living with FOP and a matched cohort of non-FOP people living in the United States (U.S.) * To describe the prevalence of...
Eligibility Criteria
Inclusion
- FOP Cohort(s):
- Living with FOP in the United States who have been identified from the IFOPA membership database
- Confirmed FOP diagnosis through IFOPA membership database will be tokenized and linked with HealthVerity's medical claims data, pharmacy claims data, laboratory data and obituary data, as defined in the protocol
- Comparator Cohort:
- People without FOP living in the U.S. randomly sampled from HealthVerity's closed medical claims data and matched to the FOP population
- Index date are defined as each person's cohort entry date. People may exit and re-enter the cohort, with the period during which they were not in the cohort excluded from the analysis
- The comparator cohort will be matched to the cohort of people with FOP on the following variables: age, sex, insurance type and first index date
Exclusion
- 1\. Failure to meet inclusion criteria
Key Trial Info
Start Date :
June 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT06064656
Start Date
June 29 2023
End Date
September 29 2023
Last Update
July 3 2025
Active Locations (1)
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1
Regeneron
Tarrytown, New York, United States, 10591