Hidradenitis Suppurativa Patient Experience With Humira Treatment

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04132388
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Electronic Reporting — OTHER
    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.
  • Adalimumab — DRUG
    Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks

Study Details

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 treatments. Patients, especially those on chronic medication therapy, inevitably miss doses. They use too little or too much therapy. They may take medications too soon or too far apart. While adherence to injection treatments tend to be better than adherence to topical or oral treatment, adherence to injections may still be poor. Traditional methods for measuring medical adherence-including questionnaires, surveys, and diaries- tend to be unreliable overestimate adherence. Chemical markers are problematic because of the tendency for patients to use their medication right before visits, so called "white coat compliance." Our research team has pioneered the use of electronic monitoring devices which measure and record the date and time of medication events to assess adherence in dermatology. The study team have demonstrated the feasibility of using such monitors to measure adherence to adalimumab in patients with psoriasis. Although only a small study, it documented a broad range of how patients use adalimumab and found that adherence was poor in about half of the patients. While the impact of psoriasis on patients' lives is large, adherence is still poor. How adherent patients with hidradenitis are to weekly adalimumab treatment is not yet well characterized.

Key Dates

Start date
Aug 20, 2020
Status verified
Sep 2022
Primary completion
Sep 7, 2022
Completion
Sep 7, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Standard-of-Care
    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.
  • Experimental: Electronic Reporting
    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.

Primary Outcome Measure

Number of days between each dose for all subjects [ Time Frame: week 12 post randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Health Sciences DermatologyWinston-SalemNorth Carolina27104-

Find similar trials in Winston-Salem, NC

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Wake Forest Health Sciences Dermatology· Winston-Salem, NC

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