Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy compared with the combination of adalimumab and a maximum of three surgeries after two years of treatment in adult patients with moderate to severe HS.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborators: Sanquin; Sanquin Plasma Products BV
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Moderate to (very) severe HS defined as a score of ≥3 points on the PGA (range 1-5) and with a DLQI of at least 11 (range 0-30).

• Indication for adalimumab: i.e. uncontrolled disease (HS) under conventional therapy and/or minor surgery.

• A diagnosis of HS for more than six months prior to baseline.

• Clearance of HS can reasonably be achieved with three surgical interventions as based on consensus between two dermatosurgeons.

• Willing and able to undergo general anaesthesia or procedural sedation and analgesia.

• Able and willing to give written informed consent and to comply with the study requirements.

Exclusion Criteria:

• 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®).

• Previous or current use of adalimumab or other anti-TNF-α therapy.

• Current or recurrent clinically significant skin condition in the HS treatment area other than HS.

• Presence of other uncontrolled clinically significant major disease.

• Pregnant and lactating women.

• Malignancy (except basal cell carcinoma), lymphoproliferative disease or a history of malignancy.

• Current use of oral antibiotics (a washout period of 14 days is required).

• Current use of oral corticosteroids (a washout period of 30 days is required).