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Outcome Measures

Primary Outcomes (1)

Cost-utility
Cost-utility: costs / point change in QALY
2 years

Secondary Outcomes (27)

Clinical efficacy using HiSCR
2 years
Clinical efficacy using change in HS-PGA
2 years
Clinical efficacy using the number of flares
2 years
Incidence and severity of treatment related adverse events
2 years
Cost-effectiveness
2 years
+22 more secondary outcomes

Study Arms (2)

Adalimumab Monotherapy

ACTIVE COMPARATOR

Adalimumab injections will be administered through subcutaneously in a weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued for 2 years in total.

Drug: Adalimumab Injection

Adalimumab + Surgery

EXPERIMENTAL

Patients will be treated with a combination of adalimumab and wide excision, with a maximum of three surgical interventions within the first year. Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2, continued until the last surgery.

Procedure: Wide ExcisionDrug: Adalimumab Injection

Interventions

Wide ExcisionProcedure

Wide excision is performed under general anaesthesia or procedural sedation and analgesia (PSA). All lesional tissue, including fibrosis, is electrosurgically removed until the area is clear. The subcutaneous fat and epithelised sinus floors are left intact where possible. The wounds are left open to heal by secondary intention.

Adalimumab + Surgery

Adalimumab InjectionDrug

Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2 until end of study or last surgery.

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Kelsey van Straalen, MDCONTACT+ 31 107040110 k.vanstraalen@erasmusmc.nl

Martijn van Doorn, MD, PhDPRINCIPAL INVESTIGATOR

Errol Prens, MD, PhDSUB INVESTIGATOR

Hessel van der Zee, MD, PhDSUB INVESTIGATOR

Allard Vossen, MDSUB INVESTIGATOR

Kelsey van Straalen, MDSUB INVESTIGATOR

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal investigator

Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (27)

Study Arms (2)

Adalimumab Monotherapy

Adalimumab + Surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (27)

Study Arms (2)

Adalimumab Monotherapy

Adalimumab + Surgery

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations