Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry)

NCT06353087 | Recruiting

• 2 other identifiers: B7451114NCT06353087
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Immune System Diseases; Janus Kinase Inhibitors

Keywords

Atopic Dermatitis; Abrocitinib; JAK inhibitors; Real world; Registry; Taiwan

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52

  EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

  Week 2, 12, 52

• Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52

  EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin)\] and lower limbs \[including buttocks\]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

  Week 2, 12, 52

• 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

  IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.

  Week 2, 12, 52

Secondary Outcomes (12)

• Duration of Abrocitinib Treatment: All Participants

  During post-index period (12 months duration post index date)

• Demographic and baseline characteristics

  During pre-index period

• Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52

  Baseline, Week 2, 4, 12, 16, 24, and 52

• Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52

  Baseline, Week 2, 4, 12, 16, 24, and 52

• Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52

  Baseline, Week 2, 4, 12, 16, 24, and 52

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult and pediatric AD patients ≥12 years with moderate-to-severe atopic dermatitis receiving abrocitinib.

You may qualify if:

• Patients aged ≥12 years
• Patients with confirmed diagnosis of moderate-to-severe AD as assessed by the physician
• Patients for whom the physician's decision has been made to newly prescribe abrocitinib in usual clinical practice conditions
• 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

You may not qualify if:

• Patients meeting any of the following criteria will not be included in the study:
• Any prior use of abrocitinib
• Simultaneous participation in a study that includes administration of any investigational drug or procedure

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Kaohsiung Medical University Hospital

Kaohsiung City, 807377, Taiwan

NOT YET RECRUITING

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung City, 83301, Taiwan

RECRUITING

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

NOT YET RECRUITING

NTUH

Taipei, 100, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, 10449, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

NOT YET RECRUITING

Tri-Service General Hospital

Taipei, 11490, R.O.C., Taiwan

NOT YET RECRUITING

Chang Gung Hospital Linkou

Taoyuan District, 333, Taiwan

NOT YET RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (8)