A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)

Completed

Conditions studied: Fibrodysplasia Ossificans Progressiva

In brief

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. This 3-year, non-interventional, two-part, natural history study is designed to gain insight into total body HO, FOP disease progression, the impact of FOP on subjects' physical functioning, and clinical features and biomarkers that may be useful in the diagnosis and monitoring of disease progression. This natural history study will also provide important information to inform the design of subsequent interventional trials.

Key facts

Study ID

NCT02322255

Run by

Clementia Pharmaceuticals Inc.

People needed

114

Starts

2014-12-18

Expected to finish

2020-04-09

Last updated by the study team

2020-06-26

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects clinically diagnosed with classical FOP with documented R206H mutation or believed to carry the R206H mutation

You may not qualify if…

• Participation in an interventional clinical research study within the 4 weeks prior to enrollment

Where it is running

• University of California San Francisco, Division of Endocrinology and Metabolism — San Francisco, California, United States
• University of Pennsylvania, Center for FOP & Related Bone Disorders — Philadelphia, Pennsylvania, United States
• Hospital Italiano de Buenos Aires, Department of Pediatrics — Buenos Aires, Argentina
• Queensland University of Technology (QUT) Institute of Health and Biomedical Innovation (IHBI) — Woolloongabba, Queensland, Australia
• Hôpital Necker-Enfants Malades, Department of Genetics — Paris, France
• Gaslini Institute, Unit of Rare Diseases, Department of Pediatrics — Genoa, Italy
• The Royal National Orthopaedic Hospital, Brockley Hill — Stanmore, Middlesex, United Kingdom

Full record on ClinicalTrials.gov

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