Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

NCT03221621 | Unknown Phase 4

• 1 other identifier: HS-COST
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Acne inversa; Adalimumab; Cost-effectiveness

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

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 Excision; Drug: Adalimumab Injection

Interventions

Wide Excision 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 + Surgery

Adalimumab Injection 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.

Also known as: Humira

Adalimumab + Surgery; Adalimumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Prothya Biosolutions: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Martijn van Doorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey van Straalen, MD

CONTACT

+ 31 107040110; k.vanstraalen@eramsusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 18, 2017
• Study Start: July 31, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)