A Study to Learn About the Study Medicine (Called Abrocitinib) in Adult Patients With Moderate to Severe Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title:

This is a Prospective, Single-arm, Multicenter, Observational Non-interventional Study (NIS) in Germany of Patient Characteristics, Usage and Effectiveness of Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250115
• Other study ID #: B7451089
• Status: Recruiting
• Start date: May 10, 2022
• Est. completion date: April 14, 2025

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):

• Are aged at least 18 years old

• Have a confirmed diagnosis of AD by a skin doctor

• Decide to start treatment with Abrocitinib as part of routine clinical practice

• Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects

Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 14, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged =18 years

• Confirmed diagnosis of AD by dermatologist prior to study inclusion

• Patient for whom the decision to initiate treatment with Abrocitinib was made as part of routine clinical practice

• Patient is eligible for Abrocitinib treatment according to Summary of Product Characteristics (SmPC)

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study

Exclusion Criteria:

• Contraindications according to SmPC

• Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period

• Patients who have received previous treatment with Abrocitinib within 3 months before study inclusion

• Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study

• Patients who are unable to consent

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Germany	Hautärztliche Gemeinschaftspraxis	Ahaus
Germany	Dr. Christiane Handrick Hautarztpraxis	Berlin
Germany	Dres. Ziethen-Stavermann GbR	Berlin
Germany	Hautarztpraxis an der Hase Studienzentrum	Bramsche
Germany	Hautärzte Braunschweig	Braunschweig
Germany	Cutaneum Praxis Dr. Buck	Hamburg
Germany	Hautarztpraxis Dr. med. Matthias Lütten	Hamburg
Germany	dermaSANA	Karlsruhe
Germany	Dr. Beate Schwarz	Langenau
Germany	Dermatologische Gemeinschaftspraxis Dres. Quist PartG	Mainz	Rheinland-pfalz
Germany	Dermatologie Mölln, Praxis Dr Segert	Mölln
Germany	Hautarztpraxis Dorittke / Kardorff	Mönchengladbach
Germany	ZENTderma, Dr. Rolf Ostendorf	Mönchengladbach
Germany	Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel	Nürnberg
Germany	Hautarztpraxis Mortazawi	Remscheid
Germany	Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski	Selters
Germany	Hautarztpraxis Dr. Hoffmann	Witten

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response based on achieving the IGA of clear (0) or almost clear (1)	Response based on Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1). IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.	Month 3
Primary	Response based on achieving the EASI-75	Response based on achieving the EASI-75 (=75% improvement from baseline). Eczema Area and Severity Index (EASI) Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Month 3
Secondary	Response based on achieving the IGA of clear (0) or almost clear (1)	Response based on IGA score of clear (0) or almost clear (1). IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.	Baseline, month 1, month 6, month 9, month 12
Secondary	Response based on achieving the EASI-75	Response based on achieving the EASI-75 (=75% improvement from baseline). EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Baseline, month 1, month 6, month 9, month 12
Secondary	Response based on achieving the EASI-90	Response based on achieving the EASI-90 (=90% improvement from baseline). EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Response based on achieving the IGA of clear (0) or almost clear (1) and a reduction from baseline of =2 points	Response based on IGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of =2 points. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Percentage change of IGA compared to baseline	Percentage change of IGA compared to baseline. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Percentage change of SCORAD compared to baseline	Percentage change of Scoring Atopic dermatitis (SCORAD) compared to baseline. SCORAD is a validated scoring index for AD for severity, combining A: extent (0-100), B: severity (0-18) and C: subjective symptoms (0-20) based on itching and sleep deprivation, each scored (0-10). The SCORAD for an individual is calculated using the formula A/5 + 7B/2 + C (may range from 0 to 103).	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Percentage of patients with EASI-75 response compared to baseline	Percentage of patients with EASI-75 (=75% improvement from baseline) response. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Absolute EASI values over time	Absolute EASI values over time. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Percentage change of EASI compared to baseline	Percentage change of EASI compared to baseline. EASI Index assesses both clinical signs of AD as well as extent of disease; scores can range from 0 to 72, with higher scores representing greater severity of AD.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Absolute change of IGA compared to baseline	Absolute change of IGA compared to baseline. IGA assesses the severity of AD (excluding scalp, palms and soles) on a 5-point scale from 0 (clear) to 4 (severe) from the investigator's perspective.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Physician´s satisfaction with treatment	Physicians´ satisfaction with treatment based on a 5 point scale from 0 (very dissatisfied) to 4 (very confident).	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Response based on achieving at least 4 points improvement of Pruritus NRS from baseline	The numeric rating scale (NRS) is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch"). Subjects are asked to rate the intensity of their average pruritus using this scale.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of Peak-Pruritus NRS over time	Change of Peak-Pruritus NRS over time. This numeric rating scale evaluates worst itching in the last 24 hours from no itching [0] to worst possible itching [10].	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of POEM from baseline	Change of Patient Oriented Eczema Measure (POEM) from baseline. This patient-reported measure assesses AD symptoms. The patient himself evaluates the frequency of occurrence and severity of 7 symptoms (such as itching and burning of the skin) within the last week, each according to a 5-point Likert scale. The maximum POEM score is 28 points.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of MOS from baseline	Change of Medical Outcomes Study Sleep Scale (MOS) from baseline. Medical Outcomes Study Sleep Scale (MOS)-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of DLQI from baseline	Change of Dermatology Life Quality-Index (DLQI) from baseline. The DLQI is a 10-item patient-reported measure that rates how much a patient´s skin problems have affected their life over the last week assigned to the following 6 dimensions: symptoms, daily life, leisure/sport, work/school, social life/relationship and treatment. For each question, 0 to 3 points are given, whereby 3 points indicate the greatest possible impairment of the QoL in the queried area. The sum of scores ranges from 0 to 30, with higher scores indicating greater impairment of quality of life.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of HADS from baseline	Change of Hospital Anxiety and Depression Scale (HADS) from baseline. HADS is a 14-item measure that identifies anxiety (7 items) and depression (7 items) among adults who are physically ill with lower scores indicating lower levels of anxiety and depression.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of EuroQol five-dimensional-five level (EQ-5D-5L) from baseline	Change of EQ-5D-5L from baseline. This is a generic instrument for measuring quality of life, including health benefits and health status on a visual analogue scale (VAS), using the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Change of PBI from baseline	Change of Patient Benefit Index (PBI) from baseline. Measurement of patient defined treatment benefits according to German and international standards, contains two one-sided questionnaires which are to be completed by the patient before and after receiving a treatment. A total of 23 possible treatment goals are evaluated on an importance scale from 0 ("not at all") to 5 ("very").	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Patients satisfaction with treatment	Patients satisfaction with treatment based on a 5-point scale from 0 (very dissatisfied) to 4 (very confident).	At all scheduled time points (Baseline, month 1, month 3, month 6, month 9, month 12)
Secondary	Number of days with topical-treatment use (TCS, TCI)	Number of medicated topical background therapy (topical corticosteroid [TCS]), topical calcineurin inhibitors [TCI]) days.	Baseline, month 1, month 3, month 6, month 9, month 12
Secondary	Number of days with emollients use	Number of days where non-medicated emollients are used.	Baseline, month 1, month 3, month 6, month 9, month 12

External Links

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