Hidradenitis SuppurativaPhase 4HS-COSTNCT03221621
Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS
A Phase 4 study testing Wide Excision and Adalimumab Injection in people with Hidradenitis Suppurativa, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Wide Excision and Adalimumab Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jul 2018to 31 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam
Kelsey van Straalen, MD, + 31 107040110, k.vanstraalen@erasmusmc.nl
Martijn van Doorn, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Wide Excision, Adalimumab Injection
- Keywords
- Acne inversa, Adalimumab, Cost-effectiveness
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide ExcisionProcedure or surgery
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 InjectionDrug
Also called Humira
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Wide Excision; Drug: Adalimumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility
Cost-utility: costs / point change in QALY
Measured: 2 years
Secondary outcomes (27)
Clinical efficacy using HiSCR
Assessment of clinical efficacy using HiSCR
Measured: 2 years
Clinical efficacy using change in HS-PGA
Assessment of clinical efficacy using change in HS-PGA
Measured: 2 years
Clinical efficacy using the number of flares
Assessment of clinical efficacy using the overall number of flares
Measured: 2 years
Incidence and severity of treatment related adverse events
Assessment of tolerability and safety by recording the incidence and severity of all treatment related adverse events.
Measured: 2 years
Cost-effectiveness
Cost-effectiveness: costs / point change in DLQI.
Measured: 2 years
Quality of life using change in EQ-5D-5L
Assessment of changes in quality of life using the EuroQol-5D-5L (EQ-5D-5L)
Measured: 2 years
Quality of life using change in DLQI
Assessment of changes in quality of life using the DLQI.
Measured: 2 years
Quality of life using change in Skindex-17
Assessment of changes in quality of life using the Skindex-17
Measured: 2 years
Treatment satisfaction
Assessment of treatment satisfaction on a 5 point Likert scale
Measured: 2 years
High sensitivity CRP
Assessment of change in high sensitivity CRP.
Measured: 2 years
Cytokines
Assessment of cytokines as possible predictive biomarkers in skin biopsies.
Measured: 3 months
Change in parameters of metabolic syndrome
Assessment of the change in parameters of metabolic syndrome: waist circumference, blood pressure, fasting plasma glucose, triglycerides, and HDL levels.
Measured: 2 years
Change in parameters of pre-diabetes
Assessment of the change in parameters of pre-diabetes using a HOMA model
Measured: 2 years
Identification of blood metabolite profiles
Identification of metabolites or metabolite profiles related to HS phenotypes, disease severity.
Measured: 3 months
Identification of metabolites associated with treatment response
Identification of metabolites (or metabolite profiles) predicting clinical response to treatment.
Measured: 3 months
Assessment of changes in metabolite (profiles)
Assessment of changes in metabolites (or metabolite profiles) in response to treatment.
Measured: 3 months
Relation between adalimumab trough concentrations and treatment response
Relation between adalimumab trough concentrations and treatment response
Measured: 3 months
Relation between adalimumab trough concentrations in serum and skin samples
Relation between adalimumab trough concentrations in serum and adalimumab trough concentrations in skin biopsies.
Measured: 3 months
Influence of patient characteristics on adalimumab serum trough concentrations
adalimumab trough concentrations
Measured: 3 months
Predictive value of early dry-blood-spots
Predictive value of early adalimumab concentrations using dry-blood-spots on treatment response at 3 months
Measured: 3 months
Objectively assessed therapy adherence using adalimumab trough concentrations
Objectively assessed therapy adherence using adalimumab trough concentrations
Measured: 2 years
Objectively assessed therapy adherence using collected syringes
Objectively assessed therapy adherence using collected syringes
Measured: 2 years
Patient reported therapy adherence using a diary
Patient reported therapy adherence using a diary recording date of every injection.
Measured: 2 years
Impact of surgery on quality of life measured with DLQI
Assessment of the impact of wide excision on quality of life measured with DLQI
Measured: 8 weeks after each surgery
Impact of surgery on work productivity measured with WPAI
Assessment of the impact of wide excision on work productivity and activity, measured with WPAI.
Measured: 8 weeks after each surgery
Wound closure time
Assessment of time to complete healing after wide excision using patient reported closure time.
Measured: through study completion, an average of 15 months
Recurrence rate
Assessment of the recurrence of HS lesions after wide excision
Measured: through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start31 Jul 2018
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prothya Biosolutions
- Responsible party
- Principal investigator, M.B.A. van Doorn, Erasmus Medical Center
- Investigators
- Martijn van Doorn, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221621
- Sponsor's protocol ID
- HS-COST
- Acronym
- HS-COST
- Status last verified
- Feb 2019
- First submitted
- 4 Jul 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'
- ClinicalTrials.gov ID
- NCT03221621
- Acronym / sponsor ID
- HS-COST / HS-COST
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Acne inversa, Adalimumab, Cost-effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Prothya Biosolutions
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adalimumab Monotherapy | Active comparator | Drug: Adalimumab InjectionAdalimumab 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. |
| Adalimumab + Surgery | Experimental | Procedure: Wide Excision, Drug: Adalimumab InjectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wide ExcisionWide 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. | Procedure or surgery | Adalimumab + Surgery |
| Adalimumab InjectionAlso: HumiraAdalimumab 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. | Drug | Adalimumab + Surgery, Adalimumab Monotherapy |
Primary outcome
Cost-utility
Time frame: 2 years
Cost-utility: costs / point change in QALY
27 secondary outcomes
Clinical efficacy using HiSCR
Time frame: 2 years
Clinical efficacy using change in HS-PGA
Time frame: 2 years
Clinical efficacy using the number of flares
Time frame: 2 years
Incidence and severity of treatment related adverse events
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Quality of life using change in EQ-5D-5L
Time frame: 2 years
Quality of life using change in DLQI
Time frame: 2 years
Quality of life using change in Skindex-17
Time frame: 2 years
Treatment satisfaction
Time frame: 2 years
High sensitivity CRP
Time frame: 2 years
Cytokines
Time frame: 3 months
Change in parameters of metabolic syndrome
Time frame: 2 years
Change in parameters of pre-diabetes
Time frame: 2 years
Identification of blood metabolite profiles
Time frame: 3 months
Identification of metabolites associated with treatment response
Time frame: 3 months
Assessment of changes in metabolite (profiles)
Time frame: 3 months
Relation between adalimumab trough concentrations and treatment response
Time frame: 3 months
Relation between adalimumab trough concentrations in serum and skin samples
Time frame: 3 months
Influence of patient characteristics on adalimumab serum trough concentrations
Time frame: 3 months
Predictive value of early dry-blood-spots
Time frame: 3 months
Objectively assessed therapy adherence using adalimumab trough concentrations
Time frame: 2 years
Objectively assessed therapy adherence using collected syringes
Time frame: 2 years
Patient reported therapy adherence using a diary
Time frame: 2 years
Impact of surgery on quality of life measured with DLQI
Time frame: 8 weeks after each surgery
Impact of surgery on work productivity measured with WPAI
Time frame: 8 weeks after each surgery
Wound closure time
Time frame: through study completion, an average of 15 months
Recurrence rate
Time frame: through study completion, an average of 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn van Doorn, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wide Excision and Adalimumab Injection in people with Hidradenitis Suppurativa, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelsey van Straalen, MD (+ 31 107040110, k.vanstraalen@eramsusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.