A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
NCT ID: NCT06064656
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2023-06-29
2023-09-29
Brief Summary
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* 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 clinical characteristics of interest and the use of key medications in people living with FOP and a matched cohort of non-FOP people living in the U.S.
* To compare the prevalence of key clinical characteristics and medication use in people living with FOP to a matched cohort of non-FOP people living in the U.S.
* To estimate the crude mortality rate among people living with FOP
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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FOP Cohort
Sub-Cohort 1: All patients with active enrollment (closed claims) during part or all the study period (2018-2023) Sub-Cohort 2: All patients with both active enrollment (closed claims) and open claims encounters during study period (2018-2022)
Non-Interventional
No study treatment will be administered in this study.
Comparator Cohort
All individuals without FOP and with active enrollment (closed claims) during part or all of the study period (2018-2023)
Non-Interventional
No study treatment will be administered in this study.
Interventions
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Non-Interventional
No study treatment will be administered in this study.
Eligibility Criteria
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Inclusion Criteria
1. Living with FOP in the United States who have been identified from the IFOPA membership database
2. 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:
1. People without FOP living in the U.S. randomly sampled from HealthVerity's closed medical claims data and matched to the FOP population
2. 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
3. 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
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron
Tarrytown, New York, United States
Countries
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Other Identifiers
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R2477-FOP-2143
Identifier Type: -
Identifier Source: org_study_id
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