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Hidradenitis SuppurativaHOPENCT02739828

Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients

An observational study of Hidradenitis Suppurativa, run by AbbVie at 11 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Adalimumab
How many people
24 participants
Where
11 sitesSweden
Study dates
7 Apr 2016to 28 Mar 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with moderate or severe Hidradenitis Suppurativa

Who may be able to join

  • Diagnosis of Hidradenitis Suppurativa
  • Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
  • Willingness to sign and date a Patient Information/Informed Consent Form

Who cannot join

  • Prior biologic treatment discontinued <6 months before the baseline visit
  • Patient not able to understand the language of the provided patient questionnaires
  • History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Sweden11 sites

  • Hallands Hospital Halmstad

    Halmstad, 301 85

  • Blekinge Hospital

    Karlskrona, SE-37185

  • Universitetssjukhuset Linköping

    Linkoping, Västra Götaland County, 581 85

  • Skaraborgs Hospital

    Skövde, 541 85

  • Karolinska Univ Sjukhuset

    Solna, 17176

  • Kungsholmens Hudklinik

    Stockholm, 112 51

  • Sodersjukhuset

    Stockholm, 11883

  • Danderyd Hospital

    Stockholm, 182 88

  • Trelleborg Hospital

    Trelleborg, 231 85

  • Norrlands Universitetssjukhus

    Umeå, 90185

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

About this study

Official title: Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients With Moderate or Severe Hidradenitis Suppurativa (HS) After 6 Months on Adalimumab Treatment (HOPE Study)

The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.

Being tested
Adalimumab
Keywords
Quality of life
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02739828
Study groupRoleWhat they receive
Patients with Hidradenitis SuppurativaPatients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice.
Receives: Biological: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in DLQI at Week 12

    DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

    Measured: Baseline, Week 12

Secondary outcomes (30)

  1. Change From Baseline in DLQI at Week 4

    DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

    Measured: Baseline, Week 4

  2. Change From Baseline in DLQI at Week 24

    DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

    Measured: Baseline, Week 24

  3. Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4

    The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.

    Measured: Baseline, Week 4

  4. Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12

    The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.

    Measured: Baseline, Week 12

  5. Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24

    The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.

    Measured: Baseline, Week 24

  6. EQ-5D Questionnaire Responses at Week 4

    The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."

    Measured: Baseline, Week 4

  7. EQ-5D Questionnaire Responses at Week 12

    The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."

    Measured: Baseline, Week 12

  8. EQ-5D Questionnaire Responses at Week 24

    The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as "some problems/no problems," "some problems/no problems/unable to do," or "none/moderate/extreme."

    Measured: Baseline, Week 24

  9. Change From Baseline in EQ-5D VAS Score at Week 4

    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.

    Measured: Baseline, Week 4

  10. Change From Baseline in EQ-5D VAS Score at Week 12

    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.

    Measured: Baseline, Week 12

  11. Change From Baseline in EQ-5D VAS Score at Week 24

    The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.

    Measured: Baseline, Week 24

  12. Change From Baseline in HSIA Overall Score at Week 4

    The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).

    Measured: Baseline, Week 4

  13. Change From Baseline in HSIA Overall Score at Week 12

    The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).

    Measured: Baseline, Week 12

  14. Change From Baseline in HSIA Overall Score at Week 24

    The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).

    Measured: Baseline, Week 24

  15. WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4

    The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 4

  16. WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12

    The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 12

  17. WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24

    The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 24

  18. WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4

    The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 4

  19. Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12

    The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 12

  20. Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24

    The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 24

  21. Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 4

  22. Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 12

  23. Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 24

  24. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4

    The 'overall activity impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall activity impairment due to health problem' was calculated based on 1 item: (Q6) to what degree did the disease impair the ability to do regular activities in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 4

  25. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 12

  26. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 24

  27. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 4

  28. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 12

  29. Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline

    The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline, Week 24

  30. Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time

    HiSCR is a clinical endpoint focusing on assessment of HS inflammatory signs and symptoms to determine the clinical effectiveness of adalimumab.

    HiSCR requires:

    • At least a 50% reduction in the total abscess and inflammatory nodule count (AN count) relative to baseline, and
    • No increase in abscess count, and
    • No increase in draining fistula count. In first bullet AN count is defined as sum of abscess count and inflammatory nodules count.

    Measured: Week 4, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study start7 Apr 2016
  3. Primary completion28 Mar 2018
  4. Study completion28 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02739828
Sponsor's protocol ID
P15-692
Acronym
HOPE
Status last verified
May 2018
First submitted
12 Apr 2016
Last updated
9 Aug 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hidradenitis Suppurativa, run by AbbVie at 11 sites in Sweden.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Sweden. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in DLQI at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02739828.

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 9 Aug 2019.

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