← Back to Search

Monoclonal Antibodies

Electronic Reporting for Hidradenitis Suppurativa

Phase 4
Waitlist Available
Led By Rita O Pichardo, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26 post randomization
Awards & highlights

Study Summary

This trial will test whether using an electronic monitor to measure and give feedback to patients about their adherence to adalimumab improves adherence to the medication.

Eligible Conditions
  • Hidradenitis Suppurativa

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26 post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of days between each dose for all subjects
Percentage of patients who achieve adherence success
Secondary outcome measures
Dermatology Life Quality Index (DLQI)
Hidradentis Suppurativa Clinical Response (HiSCR)
Number of Doses Missed
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Electronic ReportingExperimental Treatment2 Interventions
Subjects will be instructed to take adalimumab according to the labeled dosing regimen. The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
Group II: Standard-of-CareActive Control1 Intervention
Subjects will be instructed to take adalimumab according to the labeled dosing regimen. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adalimumab
2013
Completed Phase 4
~6480

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,255 Total Patients Enrolled
3 Trials studying Hidradenitis Suppurativa
88 Patients Enrolled for Hidradenitis Suppurativa
Rita O Pichardo, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
5 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Hidradenitis Suppurativa Patient Experience With Humira Treatment
2020. "Hidradenitis Suppurativa Patient Experience With Humira Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04132388.
~0 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top