Status:
WITHDRAWN
Hidradenitis Suppurativa Patient Experience With Humira Treatment
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Hidradenitis suppurativa (HS) is a chronic relapsing condition with significant psychosocial impact and morbidity, but that doesn't mean that patients will necessarily be adherent to recommended treat...
Detailed Description
This is a prospective single-center open-label randomized 6 month study. There will not be a washout period. Treatment will be for 26 weeks. Subjects will have baseline disease severity assessments. ...
Eligibility Criteria
Inclusion
- Male and female subjects ages 18 - 70
- Diagnosis of HS for which adalimumab is indicated according to the adalimumab prescribing information.
- All subjects must have a negative TB skin test according to prescribing guidelines.
- Subjects must be starting adalimumab for the first time, prescribed by their dermatologist.
Exclusion
- All experimental drugs or devices are to be discontinued at least 1 month prior to initiation of study therapy.
- Subjects who are receiving biologic therapy with a potential therapeutic impact on hidradenitis within 3 months will be excluded.
- Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
- Subjects who have received live vaccines within a 3 month period prior to enrollment will also be excluded.
- In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04132388
Start Date
August 20 2020
End Date
September 7 2022
Last Update
September 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27104