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

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ClinicalTrials.gov Identifier: NCT03221621
Recruitment Status : Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Sanquin
Information provided by (Responsible Party):
M.B.A. van Doorn, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Procedure: Wide Excision Drug: Adalimumab Injection Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of Adalimumab With Adjuvant Surgery Versus Adalimumab Monotherapy in the Treatment of Hidradenitis Suppurativa'
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
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 Name: 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.
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.

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 Name: Humira




Primary Outcome Measures :
  1. Cost-utility [ Time Frame: 2 years ]
    Cost-utility: costs / point change in QALY


Secondary Outcome Measures :
  1. Clinical efficacy using HiSCR [ Time Frame: 2 years ]
    Assessment of clinical efficacy using HiSCR

  2. Clinical efficacy using change in HS-PGA [ Time Frame: 2 years ]
    Assessment of clinical efficacy using change in HS-PGA

  3. Clinical efficacy using the number of flares [ Time Frame: 2 years ]
    Assessment of clinical efficacy using the overall number of flares

  4. 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.

  5. Cost-effectiveness [ Time Frame: 2 years ]
    Cost-effectiveness: costs / point change in DLQI.

  6. 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)

  7. Quality of life using change in DLQI [ Time Frame: 2 years ]
    Assessment of changes in quality of life using the DLQI.

  8. Quality of life using change in Skindex-17 [ Time Frame: 2 years ]
    Assessment of changes in quality of life using the Skindex-17

  9. Treatment satisfaction [ Time Frame: 2 years ]
    Assessment of treatment satisfaction on a 5 point Likert scale

  10. High sensitivity CRP [ Time Frame: 2 years ]
    Assessment of change in high sensitivity CRP.

  11. Cytokines [ Time Frame: 3 months ]
    Assessment of cytokines as possible predictive biomarkers in skin biopsies.

  12. 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.

  13. Change in parameters of pre-diabetes [ Time Frame: 2 years ]
    Assessment of the change in parameters of pre-diabetes using a HOMA model

  14. Identification of blood metabolite profiles [ Time Frame: 3 months ]
    Identification of metabolites or metabolite profiles related to HS phenotypes, disease severity.

  15. Identification of metabolites associated with treatment response [ Time Frame: 3 months ]
    Identification of metabolites (or metabolite profiles) predicting clinical response to treatment.

  16. Assessment of changes in metabolite (profiles) [ Time Frame: 3 months ]
    Assessment of changes in metabolites (or metabolite profiles) in response to treatment.

  17. Relation between adalimumab trough concentrations and treatment response [ Time Frame: 3 months ]
    Relation between adalimumab trough concentrations and treatment response

  18. 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.

  19. Influence of patient characteristics on adalimumab serum trough concentrations [ Time Frame: 3 months ]
    adalimumab trough concentrations

  20. 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

  21. Objectively assessed therapy adherence using adalimumab trough concentrations [ Time Frame: 2 years ]
    Objectively assessed therapy adherence using adalimumab trough concentrations

  22. Objectively assessed therapy adherence using collected syringes [ Time Frame: 2 years ]
    Objectively assessed therapy adherence using collected syringes

  23. Patient reported therapy adherence using a diary [ Time Frame: 2 years ]
    Patient reported therapy adherence using a diary recording date of every injection.

  24. 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

  25. 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.

  26. 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.

  27. Recurrence rate [ Time Frame: through study completion, an average of 15 months ]
    Assessment of the recurrence of HS lesions after wide excision



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221621


Contacts
Contact: Kelsey van Straalen, MD + 31 107040110 k.vanstraalen@eramsusmc.nl

Locations
Netherlands
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: Kelsey van Straalen, MD    + 31 107040110    k.vanstraalen@erasmusmc.nl   
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         
Sponsors and Collaborators
Erasmus Medical Center
Sanquin
Investigators
Principal Investigator: Martijn van Doorn, MD, PhD Erasmus MC

Responsible Party: M.B.A. van Doorn, Principal investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03221621     History of Changes
Other Study ID Numbers: HS-COST
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by M.B.A. van Doorn, Erasmus Medical Center:
Acne inversa
Adalimumab
Cost-effectiveness

Additional relevant MeSH terms:
Sweat Gland Diseases
Hidradenitis
Hidradenitis Suppurativa
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents