Clinical trial NCT06353087: Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry)
Official title: The Real-world Treatment Patterns and Clinical Outcomes in Moderate-to-severe Atopic Dermatitis (AD) Patients Receiving Abrocitinib
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Immune System Diseases
Janus Kinase Inhibitors
Keywords: Atopic Dermatitis
Abrocitinib
JAK inhibitors
Real world
Registry
Taiwan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult and pediatric AD patients ≥12 years with moderate-to-severe atopic dermatitis receiving abrocitinib.

Brief summary: This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics.


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients aged ≥12 years
2. Patients with confirmed diagnosis of moderate-to-severe AD as assessed by the physician
3. Patients for whom the physician's decision has been made to newly prescribe abrocitinib in usual clinical practice conditions
4. Evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Any prior use of abrocitinib
2. Simultaneous participation in a study that includes administration of any investigational drug or procedure

Primary outcomes:
measure: Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52
timeFrame: Week 2, 12, 52
measure: Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52
timeFrame: Week 2, 12, 52
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52
timeFrame: Week 2, 12, 52
Secondary outcomes:
measure: Duration of Abrocitinib Treatment: All Participants
timeFrame: During post-index period (12 months duration post index date)
measure: Demographic and baseline characteristics
timeFrame: During pre-index period
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52
timeFrame: Baseline, Week 2, 4, 12, and 52
measure: Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52
timeFrame: Baseline, Week 2, 4, 12, and 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52
timeFrame: Baseline, Week 2, 4, 12, and 52
measure: Change From Baseline in Patient Global Assessment (PtGA)
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
measure: Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52
timeFrame: Baseline, Week 2, 4, 12, 16, 24, and 52
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: NTUH
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Hospital Linkou
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: