Effectiveness of adalimumab in moderate to severe HS
Research type
Research Study
Full title
Effectiveness of adalimumab in moderate to severe HidrAdenitis SuppuRativa patients - a Multi cOuNtrY study in real life setting - HARMONY Study
IRAS ID
198532
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Abbive Ltd
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a prospective, observational, multicentre research study of patients who have been diagnosed with moderate to severe Hidradenitis Suppurativa (HS) and who have been prescribed adalimumab treatment according to routine clinical practice. The study is taking place in approximately 12 countries globally with 350 patients to be recruited in total.
Approximately 50 patients will be recruited in the UK from 5 secondary/tertiary care dermatology services. The patients will take part in the research via completion of 5 short questionnaires at the time they are recruited into the study and then at approximately every 12 weeks up until the 5th follow up visit which will take place at approximately week 52, according to the routine schedule of clinical visits (ie no study-specific visits). In addition, the clinical care team will collect information on patient demographics, HS disease characteristics, comorbidities, concomitant medication, treatment details and surgical interventions as recorded in the patient's medical records.
The overall aim of the study is to gather real world data concerning the effectiveness of this therapy and its impact on quality of life in patients.
All data will be provided in a pseudonymised form to researchers for data management, analysis and reporting.
Analyses will be both descriptive and comparative in nature.REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0026
Date of REC Opinion
23 Feb 2016
REC opinion
Further Information Favourable Opinion