Cost-effectiveness of adalimumab and surgery compared with adalimumab without surgery in the treatment of hidradenitis suppurativa.

Phase 1

• Conditions: Hidradenitis Suppurativa, Acne Inversa; MedDRA version: 19.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-001663-36-NL
• Lead Sponsor: Erasmus MC, Department of Dermatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-16
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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) and with a DLQI of at least 11 (range 0-30).
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 three 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified