Real-world Experience on the Use of Upadacitinib in the Treatment of Moderate-severe Adult Atopic Dermatitis (ERUDA)

NCT05989932 | Completed

• 1 other identifier: SID02
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Real-world experience on the use of Upadacitinib in the treatment of Adult moderate-severe atopic dermatitis

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Dermatology life quality index (DLQI)

  Assessment of the patient's quality of life. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life) --\> 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect

  from enrollment up to 48 weeks

• Patient-oriented eczema measure (POEM)

  The Patient Oriented Eczema Measure (POEM) is a simple, validated self-report questionnaire used for monitoring atopic eczema severity. It records seven symptoms shown to be important to patients, like itchy, sleep, bleeding ect.. Each of the seven questions carries equal weight and is scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The meaning is: 0 to 2 = Clear or almost clear; 3 to 7 = Mild eczema; 8 to 16 = Moderate eczema; 17 to 24 = Severe eczema; 25 to 28 = Very severe eczema.

  From enrollment up to 48 weeks

Interventions

Upadacitinib OTHER

Real-world on the use of Upadacitinib

Eligibility Criteria

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

Study Population

The nature of the study is descriptive. Each center is committed to enlist consecutively all adult patients diagnosed with moderate-severe atopic dermatitis treated with upadacitinib

You may qualify if:

• Age 18 years
• Signature of informed consent
• Diagnosis of moderate and/or severe DA by a dermatologist specialist
• Approval of the compassionate use of upadacitinib

You may not qualify if:

• Patient unable to give informed consent prior to any collection procedure study data
• unable to complete the procedures required for the study

Sponsors & Collaborators

• Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse: lead

Study Sites (1)

Irccs Fondazione Policlinico Gemelli

Roma, ROMA, 00168, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 14, 2023
• Study Start: December 15, 2021
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

IT (1)