Hidradenitis Suppurativa Patient Experience With Humira Treatment

NCT04132388 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB00050544
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hidradenitis Suppurativa

Keywords

adalimumab; medical adherence

Outcome Measures

Primary Outcomes (4)

• Number of days between each dose for all subjects

  assessment of adalimumab treatment

  week 12 post randomization

• Number of days between each dose for all subjects

  assessment of adalimumab treatment

  week 26 post randomization

• Percentage of patients who achieve adherence success

  percentage who have taken over 90% of correct doses of study drug

  week 12 post randomization

• Percentage of patients who achieve adherence success

  percentage who have taken over 90% of correct doses of study drug

  week 26 post randomization

Secondary Outcomes (10)

• Number of Doses Taken

  week 12 post randomization

• Number of Doses Taken

  week 26 post randomization

• Physician Global Assessment (PGA)

  week 12 post randomization

• Physician Global Assessment (PGA)

  week 26 post randomization

• Hidradentis Suppurativa Clinical Response (HiSCR)

  week 12 post randomization

Study Arms (2)

Standard-of-Care

ACTIVE COMPARATOR

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.

Drug: Adalimumab

Electronic Reporting

EXPERIMENTAL

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.

Other: Electronic Reporting; Drug: Adalimumab

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.

Electronic Reporting

Adalimumab DRUG

Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks

Also known as: Humira

Electronic Reporting; Standard-of-Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rita O Pichardo, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective single-center open-label randomized 6 month study. There will not be a washout period.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: October 18, 2019
• Study Start: August 20, 2020
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)