Cost-effectiveness of adalimumab with adjuvant surgery versus adalimumab monotherapy in the treatment of hidradenitis suppurativa. - HS-COST

Erasmus MC, Department of Dermatology0 个研究点开始时间: 2017年2月16日最近更新: 2017年10月2日

试验速览

暂无简介。

•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

•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).

发起方

Erasmus MC, Department of Dermatology