Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) (AROMA)
V
Vijay Ramakrishnan, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
N/A
1000 participants needed
2 Locations
Overview
The primary objectives of the study are:
- To longitudinally characterize the long-term effectiveness of DUPIXENT® throughd symptoms, Health-Related Quality of Life (HRQoL) relatedChronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities,d their change over-time.
- To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting withheir medical history, demographic and disease characteristics, and type 2bidities
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 treatmentving DUPIXENT® for CRSwNP
- To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Chronic Rhinosinusitis With Nasal Polyposis
-
Age: 18 Years
-
Gender: All
Key Inclusion Criteria:
- All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNPding to the respective prescribing information (Product Label or SmPC)
- Willing and able to comply with clinic visits and study-related procedures as per
- 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-specificbing information
- Any previous treatment with DUPIXENT® for any condition
- Any condition that, in the opinion of the investigator, may interfere with thebility to participate in the study per protocol
- Participation in an ongoing interventional or observational study that might, in theg physician's opinion, influence the assessments for the current study per
Updated on
01 Aug 2024.
Study ID: R668-cSNP-2072
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
