Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Regeneron Pharmaceuticals128 sites in 1 country718 target enrollmentMarch 2, 2020

ConditionsAsthma

DrugsDUPIXENT®

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: Regeneron Pharmaceuticals
Enrollment: 718
Locations: 128
Primary Endpoint: Demography
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.

This includes characterization of:

Patient demographics (eg, gender, age, and race)
Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

To characterize real-world use patterns of DUPIXENT® for asthma
To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
To collect long-term safety data on study participants in the real-world setting

Detailed Description

3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Registry

clinicaltrials.gov

Start Date

March 2, 2020

End Date

May 13, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to comply with the required clinic visits, study procedures and assessments
•Able to understand and complete study-related questionnaires
•Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
•Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information

Exclusion Criteria

•Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
•Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
•Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
•NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Outcomes

Primary Outcomes

Demography

Time Frame: At Baseline

Including gender, age, race

Baseline Characteristics

Time Frame: At Baseline

Including prior medications and procedures, medical history, asthma history, weight, height

Secondary Outcomes

Physician Assessment: - Spirometry(Baseline up to 3 years)
Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)(Baseline up to 3 Years)
Baseline Treatment Characteristics(At Baseline)
Incidence of adverse events (AEs)(Baseline up to 3 years)
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)(Baseline up to 3 Years)
Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)(Baseline up to 3 Years)
Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)(Baseline up to 3 Years)
Patient Reported Outcome: Global Patient Assessment(Baseline up to 3 Years)
Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)(Baseline up to 3 Years)
Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)(Baseline up to 3 Years)
Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12)(Baseline up to 3 Years)
Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)(Baseline up to 3 Years)
Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)(Baseline up to 3 Years)
Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)(Baseline up to 3 years)