Clinical trial NCT03221621: Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS
Official title: Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hidradenitis Suppurativa
Keywords: Acne inversa
Adalimumab
Cost-effectiveness
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Prothya Biosolutions
First posted: 2017-07-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be treated with either the combination of adalimumab and surgery or adalimumab monotherapy for two years, both according to normal clinical practice. Patients on adalimumab monotherapy will be given the possibility to crossover into Group B when they do not achieve the HiSCR after 6 months of treatment. Additionally patients will be offered treatment with infliximab, according to clinical practice, until he last surgery.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective of this randomized controlled clinical trial in a real life setting is to evaluate the cost-utility of limumab monotherapy (Group A) with the combination of adalimumab and a maximum of three surgeries (Group B) years of treatment in adult patients with moderate to severe HS.

Patients in group A will be treated with adalimumab monotherapy according to normal clinical practice and will be given the possibility to crossover into Group B when they do not achieve the HiSCR after 6 months of treatment. Additionally patients will be offered treatment with infliximab, according to clinical practice, until the last surgery. Patients in group B will receive adalimumab combined with a maximum of three adjuvant excisions of active lesions, both according to routine clinical practice.

Eligibility 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).

Primary outcomes:
measure: Cost-utility
timeFrame: 2 years
Secondary outcomes:
measure: Clinical efficacy using HiSCR
timeFrame: 2 years
measure: Clinical efficacy using change in HS-PGA
timeFrame: 2 years
measure: Clinical efficacy using the number of flares
timeFrame: 2 years
measure: Incidence and severity of treatment related adverse events
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
measure: Quality of life using change in EQ-5D-5L
timeFrame: 2 years
measure: Quality of life using change in DLQI
timeFrame: 2 years
measure: Quality of life using change in Skindex-17
timeFrame: 2 years
measure: Treatment satisfaction
timeFrame: 2 years
measure: High sensitivity CRP
timeFrame: 2 years
measure: Cytokines
timeFrame: 3 months
measure: Change in parameters of metabolic syndrome
timeFrame: 2 years
measure: Change in parameters of pre-diabetes
timeFrame: 2 years
measure: Identification of blood metabolite profiles
timeFrame: 3 months
measure: Identification of metabolites associated with treatment response
timeFrame: 3 months
measure: Assessment of changes in metabolite (profiles)
timeFrame: 3 months
measure: Relation between adalimumab trough concentrations and treatment response
timeFrame: 3 months
measure: Relation between adalimumab trough concentrations in serum and skin samples
timeFrame: 3 months
measure: Influence of patient characteristics on adalimumab serum trough concentrations
timeFrame: 3 months
measure: Predictive value of early dry-blood-spots
timeFrame: 3 months
measure: Objectively assessed therapy adherence using adalimumab trough concentrations
timeFrame: 2 years
measure: Objectively assessed therapy adherence using collected syringes
timeFrame: 2 years
measure: Patient reported therapy adherence using a diary
timeFrame: 2 years
measure: Impact of surgery on quality of life measured with DLQI
timeFrame: 8 weeks after each surgery
measure: Impact of surgery on work productivity measured with WPAI
timeFrame: 8 weeks after each surgery
measure: Wound closure time
timeFrame: through study completion, an average of 15 months
measure: Recurrence rate
timeFrame: through study completion, an average of 15 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Martijn van Doorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: