HS Pre/Post Surgical Study Protocol v12_0
Research type
Research Study
Full title
Pre/Post Surgical Study of Subject and Clinician Reported Outcomes in Subjects with Hidradenitis Suppurativa
IRAS ID
161115
Contact name
Nicola Bonner
Contact email
Sponsor organisation
AbbVie
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
The primary objective of this prospective, multi-visit, non-interventional study is to assess pre- and post-surgical patient-reported outcomes (PROs) to identify the unmet needs after surgery. Outcomes associated with surgical treatment, impacts associated with HS, and clinical outcomes, including lesions and clinician reported disease severity, will be evaluated. This is an exploratory study involving up to 20 subjects with HS and their clinicians in the UK. Subject recruitment will take approximately five months. For recruited subjects, the observational period for the study will be at least 97 days (the pre surgical visit will take place at least 7 days prior to the surgery [Timepoint 1] and the post-surgical visit will take place 90 days after the surgery [Timepoint 2]). Timepoint 1 (Day 1 - Baseline) will be conducted in the clinicians’ office pre surgery, enabling sites to screen subjects and collect the first round of study documents and questionnaires. Following surgery, subjects will be mailed the second round of questionnaires. They will then complete the questionnaires and mail them back to the study sites via a pre-paid return envelope (Timepoint 2, Day ~90). Study sites will be required to send all data back to Adelphi Values via mail. Apart from completion of study questionnaires by subjects and clinicians, no tests, procedures, or pharmacological medication will be tested by Adelphi Values as part of this study. This is a multinational study also being conducted in the USA and Germany, for a total sample of up to 65 subject and their clinicians.
REC name
Wales REC 6
REC reference
18/WA/0301
Date of REC Opinion
3 Sep 2018
REC opinion
Favourable Opinion