Study identification

EU PAS number

EUPAS41565

Study ID

42822

Official title and acronym

Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (AROMA)

DARWIN EU® study

No

Study countries

Canada
France
Germany
Italy
Japan
Netherlands
United States

Study description

The primary objectives of the study are: • To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time. • To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities The secondary objectives of the study are: • To characterize real-world utilization of DUPIXENT® for patients with CRSwNP • To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP • To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Study Director Regeneron

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

Regeneron Pharmaceuticals, Inc., Sanofi
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable