Effectiveness of adalimumab combined with adjuvant surgery versus adalimumab monotherapy in the treatment of hidradenitis suppurativa.

Phase 4

Recruiting

• Conditions: 10040795; 10040798; acne inversa

• Registration Number: NL-OMON50218
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following inclusion criteria:
1. Age >=18 years.
2. Moderate to (very) severe HS defined as a score of >=3 points on the PGA
(range 1-5)
3. Indication for adalimumab: uncontrolled disease (HS) under conventional
therapy and/or minor surgery.
4. A diagnosis of HS for more than six months prior to baseline.
5. Clearance of HS can reasonably be achieved with two surgical interventions
as based on consensus between two dermatosurgeons.
6. Willing and able to undergo general anaesthesia.
7. Able and willing to give written informed consent and to comply with the
study requirements.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Contraindication for treatment with adalimumab (sepsis or risk of sepsis,
active or latent tuberculosis, serious active local and/or chronic infections,
heart failure NYHA class III/IV, severe liver disease, pre-existing HIV, active
viral hepatitis, demyelinating disease, or allergy to adalimumab or any other
ingredients of HUMIRA®).
2. Previous failure or current use of adalimumab or other anti-TNF-a therapy.
3. Current or recurrent clinically significant skin condition in the HS
treatment area other than HS.
4. Presence of other uncontrolled clinically significant major disease.
5. Pregnant and lactating women.
6. Malignancy (except basal cell carcinoma), lymphoproliferative disease or a
history of malignancy.
7. Current use of oral antibiotics (a washout period of 14 days is required).
8. Current use of oral corticosteroids (a washout period of 30 days is
required).
9. Previous biologic use; a wash-out of at least 5 half-lifes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is the change in IHS4 (delta IHS4) at the last<br /><br>visit (12 months or the last visit before dropout). The IHS4 is calculated by<br /><br>the following formula: Inflammatory nodules x 1 + Abscesses x 2 + Draining<br /><br>fistulas x 4. </p><br>