Cost-effectiveness of Adalimumab and Surgery vs Adalimumab in HS

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    128
  • sponsor
    Erasmus Medical Center
Updated on 22 January 2021

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.

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.

Details
Condition Hidradenitis Suppurativa, Acne Inversa
Treatment Adalimumab Injection, Wide Excision
Clinical Study IdentifierNCT03221621
SponsorErasmus Medical Center
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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- 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)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note