REGISTRY OF ASTHMA PATIENTS INITIATING DUPIXENT (RAPID)

JRCT ID: jRCT1030210488

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Asthma, Bronchial
• Date of first enrollment: 02/03/2020
• Target sample size: 46
• Countries of recruitment: USA,Japan,Puerto Rico,Japan,France,Japan,Italy,Japan,Sweden,Japan,Denmark,Japan
• Study type: Observational

Outcome(s)

Primary Outcome

-Assessment of patient demographics (eg, gender, age, and race)
-Assessment of patient baseline characteristics (eg, prior medications and procedures,
medical history, asthma history, weight, height)

Secondary Outcome

-Descriptive summaries of DUPIXENT and other asthma treatments used during the study, including doses and dose frequency, treatment duration, asthma treatment
associations (eg, DUPIXENT monotherapy, DUPIXENT + ICS, DUPIXENT + ICS + additional controllers), and reasons for initiation and for discontinuation/switching
-Time course of clinical outcome parameters - patient reported outcomes (PROs) - for asthma and relevant comorbidities
-Descriptive summary of adverse events (AEs) reported in the study

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

A patient must meet the following criteria to be eligible for inclusion in the study:
1. Male or female, 12 years or older at the baseline visit
2. Initiating treatment with DUPIXENT for a primary indication of asthma according to the country-specific prescribing information
3. Willing and able to comply with the required clinic visits, study procedures and assessments
4. Able to understand and complete study-related questionnaires
5. Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required

Exclude criteria

A patient who meets any of the following criteria will be excluded from the study
1. Patients who have a contraindication to DUPIXENT according to the country-specific prescribing information
2. 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
3. Any condition that, in the opinion of the investigator, may interfere with ability of the patient to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other medical, social, or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

Related Information

• Primary Sponsor: Clinical Trials Administrator
• Secondary Sponsor: Sanofi K. K.
• Secondary ID(s): NCT04287621,EUPAS41963