Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) (AROMA)

Regeneron Pharmaceuticals

Status: Active, not recruiting

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Treatments: Drug: DUPIXENT®

Study type: Observational

Funder types: Industry

Identifiers

NCT04959448

42822 (Registry Identifier)

R668-cSNP-2072

Details and patient eligibility

About

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

Enrollment: 717 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
• Willing and able to comply with clinic visits and study-related procedures as per protocol
• Provide informed consent signed by study patient or legally acceptable representative
• Able to understand and complete study-related questionnaires as per protocol

Key Exclusion Criteria:

• Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
• Any previous treatment with DUPIXENT® for any condition
• Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol
• Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol