Hidradenitis SuppurativaPhase 4NCT04132388
Hidradenitis Suppurativa Patient Experience With Humira Treatment
A Phase 4 study testing Electronic Reporting and Adalimumab in people with Hidradenitis Suppurativa, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Electronic Reporting and Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 7 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences Dermatology
Winston-Salem, North Carolina, 27104
About this study
Official title: Hidradenitis Suppurativa Patients' Experience of Treatment With Adalimumab
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.
Read the 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. Subjects will be instructed to take adalimumab according to the labelled dosing regimen. Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.
The 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 Endpoints: Adherence to adalimumab treatment
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Electronic Reporting, Adalimumab
- Keywords
- adalimumab, medical adherence
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic ReportingOther
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.
AdalimumabDrug
Also called Humira
Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Electronic Reporting; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days between each dose for all subjects
assessment of adalimumab treatment
Measured: week 12 post randomization
Number of days between each dose for all subjects
assessment of adalimumab treatment
Measured: week 26 post randomization
Percentage of patients who achieve adherence success
percentage who have taken over 90% of correct doses of study drug
Measured: week 12 post randomization
Percentage of patients who achieve adherence success
percentage who have taken over 90% of correct doses of study drug
Measured: week 26 post randomization
Secondary outcomes (10)
Number of Doses Taken
Measured by MEMs cap
Measured: week 12 post randomization
Number of Doses Taken
Measured by MEMs cap
Measured: week 26 post randomization
Physician Global Assessment (PGA)
Assessment score ranges from 0 to 5 with a higher score denoting a worse outcome.
Measured: week 12 post randomization
Physician Global Assessment (PGA)
Assessment score ranges from 0 to 5 with a higher score denoting a worse outcome.
Measured: week 26 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)
Hidradenitis Suppurativa Clinical Response (HiSCR) measures number of inflammatory lesions.
Measured: week 12 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)
Hidradenitis Suppurativa Clinical Response (HiSCR) measures number of inflammatory lesions.
Measured: week 26 post randomization
Dermatology Life Quality Index (DLQI)
Scale ranges from 0 to 30 with a higher rating denoting a worse outcome.
Measured: week 12 post randomization
Dermatology Life Quality Index (DLQI)
Scale ranges from 0 to 30 with a higher rating denoting a worse outcome.
Measured: week 26 post randomization
Number of Doses Missed
Measured: week 26 post randomization
Total Time in Study
Measured: week 26 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start20 Aug 2020 (estimated)
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Why it stopped: Sponsor and site agreed the research would not happen now; several delays and other issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective single-center open-label randomized 6 month study. There will not be a washout period.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita O Pichardo, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132388
- Sponsor's protocol ID
- IRB00050544
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidradenitis Suppurativa Patients' Experience of Treatment With Adalimumab
- ClinicalTrials.gov ID
- NCT04132388
- Acronym / sponsor ID
- IRB00050544
- Conditions
- Hidradenitis Suppurativa
- Keywords
- adalimumab, medical adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor and site agreed the research would not happen now; several delays and other issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 20 Aug 2020 (estimated)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Subjects will be instructed to take adalimumab according to the labelled dosing regimen. Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.
The 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 Endpoints: Adherence to adalimumab treatment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective single-center open-label randomized 6 month study. There will not be a washout period.
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care | Active comparator | Drug: AdalimumabSubjects 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. |
| Electronic Reporting | Experimental | Other: Electronic Reporting, Drug: AdalimumabSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic ReportingThe 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 |
| AdalimumabAlso: HumiraSubjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks | Drug | Electronic Reporting, Standard-of-Care |
Primary outcome
Number of days between each dose for all subjects
Time frame: week 12 post randomization
assessment of adalimumab treatment
Number of days between each dose for all subjects
Time frame: week 26 post randomization
assessment of adalimumab treatment
Percentage of patients who achieve adherence success
Time frame: week 12 post randomization
percentage who have taken over 90% of correct doses of study drug
Percentage of patients who achieve adherence success
Time frame: week 26 post randomization
percentage who have taken over 90% of correct doses of study drug
10 secondary outcomes
Number of Doses Taken
Time frame: week 12 post randomization
Number of Doses Taken
Time frame: week 26 post randomization
Physician Global Assessment (PGA)
Time frame: week 12 post randomization
Physician Global Assessment (PGA)
Time frame: week 26 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)
Time frame: week 12 post randomization
Hidradentis Suppurativa Clinical Response (HiSCR)
Time frame: week 26 post randomization
Dermatology Life Quality Index (DLQI)
Time frame: week 12 post randomization
Dermatology Life Quality Index (DLQI)
Time frame: week 26 post randomization
Number of Doses Missed
Time frame: week 26 post randomization
Total Time in Study
Time frame: week 26 post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita O Pichardo, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Electronic Reporting and Adalimumab in people with Hidradenitis Suppurativa, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days between each dose for all subjects (time frame: week 12 post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.