Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

NCT ID: NCT03221621

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2022-07-31

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab Monotherapy

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.

Group Type: ACTIVE_COMPARATOR

Adalimumab Injection

Intervention Type: DRUG

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.

Adalimumab + Surgery

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.

Group Type: EXPERIMENTAL

Wide Excision

Intervention Type: PROCEDURE

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 Injection

Intervention Type: DRUG

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.

Interventions

Wide Excision

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.

Intervention Type: PROCEDURE

Adalimumab Injection

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.

Intervention Type: DRUG

Other Intervention Names

Humira

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prothya Biosolutions

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

M.B.A. van Doorn

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martijn van Doorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Kelsey van Straalen, MD

Role: CONTACT

k.vanstraalen@eramsusmc.nl

+ 31 107040110

Facility Contacts

Kelsey van Straalen, MD

Role: primary

k.vanstraalen@erasmusmc.nl

+ 31 107040110

Other Identifiers

HS-COST

Identifier Type: -

Identifier Source: org_study_id