A Non-Interventional Study of Clinical Characteristics and Mortality of US Patients With Fibrodysplasia Ossificans Progressiva (FOP)

Fibrodysplasia Ossificans Progressiva (FOP) Clinical Trial

Official title:

Clinical Characteristics and Mortality in Patients With Fibrodysplasia Ossificans Progressiva (FOP): A Non-Interventional US National Retrospective Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064656
• Other study ID #: R2477-FOP-2143
• Status: Completed
• Start date: June 29, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 29, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Confirmed FOP diagnosis

2. Members from the International Fibrodysplasia Ossificans Progressiva Association (iFOPA) cohort who have opted-in to be tokenized by Health Verity Marketplace

3. 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:

1. Failure to meet inclusion criteria

Related Conditions & MeSH terms

• Fibrodysplasia Ossificans Progressiva (FOP)

Intervention

Other:
• Non-Interventional
No study treatment will be administered on this study.

Locations

Country	Name	City	State
United States	Regeneron	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristics		Up to 5 years
Primary	Prevalence of cardiovascular disease		Up to 5 years
Primary	Prevalence of metabolic disease		Up to 5 years
Primary	Prevalence of hematology disease		Up to 5 years
Primary	Prevalence of infection		Up to 5 years
Primary	Prevalence of respiratory disease		Up to 5 years
Primary	Prevalence of reproductive disease		Up to 5 years
Primary	Prevalence of neurologic disorders		Up to 5 years
Primary	Prevalence of skeletal disorders		Up to 5 years
Primary	Prevalence of gastrointestinal disease		Up to 5 years
Primary	Prevalence of deafness		Up to 5 years
Primary	Prevalence of dermatologic disorders		Up to 5 years
Primary	Prevalence of neoplasms		Up to 5 years
Primary	Average number of prescriptions per FOP patient per year		Up to 5 years
Primary	Cumulative number of prescriptions per FOP patient		Up to 5 years
Primary	Incidence of all-cause death		Up to 5 years