Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS (HS-COST)

February 7, 2019 updated by: M.B.A. van Doorn, Erasmus Medical Center

Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC
        • Contact:
        • Principal Investigator:
          • Martijn van Doorn, MD, PhD
        • Sub-Investigator:
          • Errol Prens, MD, PhD
        • Sub-Investigator:
          • Hessel van der Zee, MD, PhD
        • Sub-Investigator:
          • Allard Vossen, MD
        • Sub-Investigator:
          • Kelsey van Straalen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: 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.
Other Names:
  • Humira
Experimental: 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.
Drug: 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.
Other Names:
  • Humira
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cost-utility
Time Frame: 2 years
Cost-utility: costs / point change in QALY
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical efficacy using HiSCR
Time Frame: 2 years
Assessment of clinical efficacy using HiSCR
2 years
Clinical efficacy using change in HS-PGA
Time Frame: 2 years
Assessment of clinical efficacy using change in HS-PGA
2 years
Clinical efficacy using the number of flares
Time Frame: 2 years
Assessment of clinical efficacy using the overall number of flares
2 years
Incidence and severity of treatment related adverse events
Time Frame: 2 years
Assessment of tolerability and safety by recording the incidence and severity of all treatment related adverse events.
2 years
Cost-effectiveness
Time Frame: 2 years
Cost-effectiveness: costs / point change in DLQI.
2 years
Quality of life using change in EQ-5D-5L
Time Frame: 2 years
Assessment of changes in quality of life using the EuroQol-5D-5L (EQ-5D-5L)
2 years
Quality of life using change in DLQI
Time Frame: 2 years
Assessment of changes in quality of life using the DLQI.
2 years
Quality of life using change in Skindex-17
Time Frame: 2 years
Assessment of changes in quality of life using the Skindex-17
2 years
Treatment satisfaction
Time Frame: 2 years
Assessment of treatment satisfaction on a 5 point Likert scale
2 years
High sensitivity CRP
Time Frame: 2 years
Assessment of change in high sensitivity CRP.
2 years
Cytokines
Time Frame: 3 months
Assessment of cytokines as possible predictive biomarkers in skin biopsies.
3 months
Change in parameters of metabolic syndrome
Time Frame: 2 years
Assessment of the change in parameters of metabolic syndrome: waist circumference, blood pressure, fasting plasma glucose, triglycerides, and HDL levels.
2 years
Change in parameters of pre-diabetes
Time Frame: 2 years
Assessment of the change in parameters of pre-diabetes using a HOMA model
2 years
Identification of blood metabolite profiles
Time Frame: 3 months
Identification of metabolites or metabolite profiles related to HS phenotypes, disease severity.
3 months
Identification of metabolites associated with treatment response
Time Frame: 3 months
Identification of metabolites (or metabolite profiles) predicting clinical response to treatment.
3 months
Assessment of changes in metabolite (profiles)
Time Frame: 3 months
Assessment of changes in metabolites (or metabolite profiles) in response to treatment.
3 months
Relation between adalimumab trough concentrations and treatment response
Time Frame: 3 months
Relation between adalimumab trough concentrations and treatment response
3 months
Relation between adalimumab trough concentrations in serum and skin samples
Time Frame: 3 months
Relation between adalimumab trough concentrations in serum and adalimumab trough concentrations in skin biopsies.
3 months
Influence of patient characteristics on adalimumab serum trough concentrations
Time Frame: 3 months
adalimumab trough concentrations
3 months
Predictive value of early dry-blood-spots
Time Frame: 3 months
Predictive value of early adalimumab concentrations using dry-blood-spots on treatment response at 3 months
3 months
Objectively assessed therapy adherence using adalimumab trough concentrations
Time Frame: 2 years
Objectively assessed therapy adherence using adalimumab trough concentrations
2 years
Objectively assessed therapy adherence using collected syringes
Time Frame: 2 years
Objectively assessed therapy adherence using collected syringes
2 years
Patient reported therapy adherence using a diary
Time Frame: 2 years
Patient reported therapy adherence using a diary recording date of every injection.
2 years
Impact of surgery on quality of life measured with DLQI
Time Frame: 8 weeks after each surgery
Assessment of the impact of wide excision on quality of life measured with DLQI
8 weeks after each surgery
Impact of surgery on work productivity measured with WPAI
Time Frame: 8 weeks after each surgery
Assessment of the impact of wide excision on work productivity and activity, measured with WPAI.
8 weeks after each surgery
Wound closure time
Time Frame: through study completion, an average of 15 months
Assessment of time to complete healing after wide excision using patient reported closure time.
through study completion, an average of 15 months
Recurrence rate
Time Frame: through study completion, an average of 15 months
Assessment of the recurrence of HS lesions after wide excision
through study completion, an average of 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prothya Biosolutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martijn van Doorn, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-COST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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