A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Completed
- Conditions
- Fibrodysplasia Ossificans Progressiva (FOP)
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT06064656
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Primary Objective(s):
* To describe the demographic characteristics of people living with FOP
* To describe the prevalence of clinical characteristics of interest in people living with FOP
* To describe the use of key medications in people living with FOP
* To estimate the crude mortality rate among people with FOP
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
Inclusion Criteria
- Confirmed FOP diagnosis
- Members from the International Fibrodysplasia Ossificans Progressiva Association (iFOPA) cohort who have opted-in to be tokenized by Health Verity Marketplace
- Must be enrolled in the closed medical claims data source for any duration of time between January 1, 2018 and December 31, 2022
Exclusion Criteria
- Failure to meet inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sub-Cohort 1 Non-Interventional All patients with active enrollment (closed claims) during part or all the study period. Sub-Cohort 2 Non-Interventional All patients with active enrollment (closed claims) augmented with open claims
- Primary Outcome Measures
Name Time Method Prevalence of dermatologic disorders 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 deafness Up to 5 years Demographic characteristics 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 neoplasms Up to 5 years Average number of prescriptions per FOP patient per year Up to 5 years Cumulative number of prescriptions per FOP patient Up to 5 years Incidence of all-cause death Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Regeneron
🇺🇸Tarrytown, New York, United States