Urine Sample Collection From FOP Patients

Completed

Conditions studied: Fibrodysplasia Ossificans Progressiva

In brief

The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.

Key facts

Study ID

NCT02066324

Run by

Novartis Pharmaceuticals

People needed

25

Starts

2013-11-01

Expected to finish

2014-08-01

Last updated by the study team

2015-03-12

Who can join

Age: 5 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
• Physically able to provide first-morning urine sample of at least 30 mL
• Able to communicate well with the investigator, to understand and comply with the requirements of the study
• About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function

You may not qualify if…

• Diagnosis of diabetes
• Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
• Diagnosis of cancer other than nonmelanomatous skin cancer.

Where it is running

• Novartis Investigative Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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