Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting

Completed

• Conditions: Hidradenitis Suppurativa

• Registration Number: NCT02786576
• Lead Sponsor: AbbVie

Brief Summary

This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Study Start: 2016-07-05
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Status Verified: 2019-09
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
• The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
• Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)

Exclusion Criteria

• Participants in a clinical interventional study
• Participants treated with adalimumab prior to baseline visit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response	At Week 12	Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in Dermatology Quality of Life Index (DLQI)	From Week 0 to Week 52	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Proportion of participants with moderate to severe HS who achieve a clinical response	Up to week 52	Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)

Trial Locations

Locations (83)

Krankenanstalt Rudolfstiftung /ID# 166804; 🇦🇹 Vienna, Wien, Austria

LKH-Univ. Klinikum Graz /ID# 166802; 🇦🇹 Graz, Austria

Klinikum Wels - Grieskirchen /ID# 158017; 🇦🇹 Wels, Austria

UZ Brussel /ID# 154218; 🇧🇪 Jette, Bruxelles-Capitale, Belgium

Cliniques Universitaires Saint Luc /ID# 154217; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

CHU de Liege /ID# 154220; 🇧🇪 Liège, Liege, Belgium

UZ Gent /ID# 154221; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

CLIDERM Bruxelles /ID# 154232; 🇧🇪 Anderlecht, Belgium

PP Anderlecht /ID# 154230; 🇧🇪 Anderlecht, Belgium

CHIREC- City Clinic Louise /ID# 154227; 🇧🇪 Brussels, Belgium

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