NCT04132388

Hidradenitis Suppurativa Patient Experience With Humira Treatment

Withdrawn Phase 4 Last updated 29 September 2022

What this trial tests

Phase 4 trial testing Electronic Reporting in Hidradenitis Suppurativa. Withdrawn.

Timeline

20 August 2020

Primary endpoint
7 September 2022

7 September 2022

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Start date	20 August 2020
Primary completion	7 September 2022
Estimated completion	7 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Electronic Reporting
• Adalimumab (ADALIMUMAB) — full drug profile →

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 70, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hidradenitis suppurativa (HS) is a chronic relapsing condition with significant psychosocial impact and morbidity, but that doesn't mean that patients will necessarily be adherent to recommended treatments. Patients, especially those on chronic medication therapy, inevitably miss doses. They use too little or too much therapy. They may take medications too soon or too far apart. While adherence to injection treatments tend to be better than adherence to topical or oral treatment, adherence to injections may still be poor.

Traditional methods for measuring medical adherence-including questionnaires, surveys, and diaries- tend to be unreliable overestimate adherence. Chemical markers are problematic because of the tendency for patients to use their medication right before visits, so called "white coat compliance." Our research team has pioneered the use of electronic monitoring devices which measure and record the date and time of medication events to assess adherence in dermatology. The study team have demonstrated the feasibility of using such monitors to measure adherence to adalimumab in patients with psoriasis. Although only a small study, it documented a broad range of how patients use adalimumab and found that adherence was poor in about half of the patients. While the impact of psoriasis on patients' lives is large, adherence is still poor. How adherent patients with hidradenitis are to weekly adalimumab treatment is not yet well characterized.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hidradenitis Suppurativa: Where We Are and Where We Are Going.
   Scala E, Cacciapuoti S, Garzorz-Stark N, Megna M, et al · · 2021 · cited 85× · PMID 34440863 · DOI 10.3390/cells10082094