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Primary Objective(s):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| Comparator Cohort | All individuals without FOP and with active enrollment (closed claims) during part or all of the study period (2018-2023) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | No study treatment will be administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographic characteristics | Up to 5 years | |
| Prevalence of cardiovascular disease | Up to 5 years | |
| Prevalence of metabolic disease | Up to 5 years | |
| Prevalence of hematology disease | Up to 5 years | |
| Prevalence of infection | Up to 5 years | |
| Prevalence of respiratory disease | Up to 5 years | |
| Prevalence of reproductive disease | Up to 5 years | |
| Prevalence of neurologic disorders | Up to 5 years | |
| Prevalence of skeletal disorders | Up to 5 years | |
| Prevalence of gastrointestinal disease | Up to 5 years | |
| Prevalence of hearing loss | Up to 5 years | |
| Prevalence of dermatologic disorders |
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Inclusion Criteria:
FOP Cohort(s):
Comparator Cohort:
Exclusion Criteria:
1. Failure to meet inclusion criteria
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FOP Cohort(s):
The International Fibrodysplasia Ossificans Progressiva Association (IFOPA) membership has 235 confirmed people living with FOP in the US. From this membership database, there were 131 members or next of kin of members who opted-in to allow for the tokenization of their membership data to occur.
Comparator Cohort:
A random sample of 100,000 people from an insured population without FOP diagnosis living in the U.S. and matched to the FOP population.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron | Tarrytown | New York | 10591 | United States |
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| ID | Term |
|---|---|
| D009221 | Myositis Ossificans |
| D030342 | Genetic Diseases, Inborn |
| D009999 | Ossification, Heterotopic |
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Up to 5 years |
| Prevalence of neoplasms | Up to 5 years |
| Average number of dispensations per FOP patient per year | Up to 5 years |
| Cumulative number of dispensations per FOP patient | Up to 5 years |
| Incidence of all-cause death | FOP Sub-Cohorts 1 and 2 Only | Up to 5 years |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |