Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

• ClinicalTrials.gov Identifier: NCT04287621
• Recruitment Status: Recruiting
• First Posted: February 27, 2020
• Last Update Posted: March 30, 2020
• Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Study Description

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.

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

Condition or disease	Intervention/treatment
Asthma	Drug: DUPIXENT®

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 156 Weeks
• Official Title: Registry of Asthma Patients Initiating DUPIXENT® (RAPID)
• Actual Study Start Date: March 2, 2020
• Estimated Primary Completion Date: July 7, 2025
• Estimated Study Completion Date: July 7, 2025

Groups and Cohorts

Intervention Details:

• Drug: DUPIXENT®
  There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.
  Other Names:

  • dupilumab
  • REGN668
  • SAR231893

Outcome Measures

Primary Outcome Measures :

1. Baseline Patient Characteristics [ Time Frame: Baseline up to 3 years ]
   Demographics includes but is not limited to: gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information and insurance information
2. Baseline Disease Characteristics [ Time Frame: Baseline up to 3 years ]
   Medical History includes but is not limited to: family history of relevant diseases, atopic medical history, asthma history and substance use

Secondary Outcome Measures :

1. Baseline Treatment Characteristics [ Time Frame: Baseline up to 3 years ]
   Including but not limited to: Dose, Dose Frequency, Treatment Duration and asthma treatment associations
2. Incidence and severity of adverse events (AEs) [ Time Frame: Baseline up to 3 years ]
3. Physician Assessment: - Change of Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline up to 3 years ]
   Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
4. Physician Assessment: Change of Fractional exhaled Nitric Oxide (FeNO) [ Time Frame: Baseline up to 3 Years ]
   FeNO is a surrogate marker for airway inflammation. FeNO is analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second and reported in ppb.
5. Participant Assessment: Change of Asthma Control Questionnaire, 6-item (ACQ-6) [ Time Frame: Baseline up to 3 Years ]
   ACQ-6 had 6 questions which assessed the most common asthma symptoms during the previous week (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled) Higher score indicates lower asthma control.
6. Participant Assessment: Change of Mini Asthma Quality of Life Questionnaire (MiniAQLQ) [ Time Frame: Baseline up to 3 Years ]
   A disease-specific patient-reported outcome 15-item questionnaire in four domains (symptoms, activity limitation, emotions, environment), which are answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment).
7. Participant Assessment: Change of Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS) [ Time Frame: Baseline up to 3 Years ]
   Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.
8. Participant Assessment: Change of Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12) [ Time Frame: Baseline up to 3 Years ]
   RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).
9. Participant Assessment: Change of Sino-Nasal Outcome Test (SNOT-22) [ Time Frame: Baseline up to 3 Years ]
   A questionnaire to assess the impact of chronic rhinosinusitis on quality of life. It is a 22 -item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
10. Participant Assessment: Change of Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline up to 3 Years ]
    A questionnaire responding to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on frequency of these disease symptoms during the past week (ie, 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days) with a scoring system of 0 to 28.
11. Participant Assessment: Change of Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma) [ Time Frame: Baseline up to 3 Years ]
    Questionnaire to assess the impact of asthma on productivity of adult patients who are working, either part-time or full-time. If adult patients are not working at baseline, they will not complete the questionnaire. The WPAI-asthma is a 6-item, validated questionnaire to measure impairments in work and activities over a 7-day recall period. The WPAI-asthma outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
12. Participant Assessment: Changes of Healthcare Utilization [ Time Frame: Baseline up to 3 years ]
    Measured using directly collected information from medical, hospital, and pharmacy records

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for asthma according to the country-specific prescribing information.

Criteria

Key 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

Key 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 may apply.

Contacts and Locations

Contacts

Contact: Clinical Trials Administrator; 844-734-6643; clinicaltrials@regeneron.com

Locations

United States, Arizona

Regeneron Study Site; Recruiting

Gilbert, Arizona, United States, 85234

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

More Information

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04287621
• Other Study ID Numbers: R668-AS-1885
• First Posted: February 27, 2020
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases