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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Hidradenitis Suppurativa | Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Adalimumab |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4 |
| Change From Baseline in DLQI at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with moderate or severe Hidradenitis Suppurativa
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitetssjukhuset Linköping | Linkoping | Västra Götaland County | 581 85 | Sweden | ||
| Hallands Hospital Halmstad |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Hidradenitis Suppurativa | Participants with moderate or severe hidradenitis suppurativa (HS) treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Hidradenitis Suppurativa | Participants with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
|
Up to 24 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Hidradenitis Suppurativa | Patients with moderate or severe HS treated prescribed adalimumab according to the Swedish Summary of Product Characteristics and treated as per routine clinical practice. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2017 | Mar 21, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 7, 2017 | Jun 27, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| Baseline, Week 24 |
| 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. | Baseline, Week 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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." | Baseline, Week 4 |
| 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." | Baseline, Week 12 |
| 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." | Baseline, Week 24 |
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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). | Baseline, Week 4 |
| 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). | Baseline, Week 12 |
| 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). | Baseline, Week 24 |
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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. | Baseline, Week 4 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 24 |
| 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:
| Week 4, 12 and 24 |
| Halmstad |
| 301 85 |
| Sweden |
| Blekinge Hospital | Karlskrona | SE-37185 | Sweden |
| Skaraborgs Hospital | Skövde | 541 85 | Sweden |
| Karolinska Univ Sjukhuset | Solna | 17176 | Sweden |
| Kungsholmens Hudklinik | Stockholm | 112 51 | Sweden |
| Sodersjukhuset | Stockholm | 11883 | Sweden |
| Danderyd Hospital | Stockholm | 182 88 | Sweden |
| Trelleborg Hospital | Trelleborg | 231 85 | Sweden |
| Norrlands Universitetssjukhus | Umeå | 90185 | Sweden |
| Akademiska sjukhuset | Uppsala | 751 85 | Sweden |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Dermatology Life Quality Index (DLQI) | 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. | Mean | Standard Deviation | units on a scale |
|
| Participant's Global Assessment of Skin Pain - Numerical Rating Scale (NRS) | 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 visual analogue scale (VAS) response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each. | Mean | Standard Deviation | units on a scale |
|
| EuroQual 5 Dimensions (EQ-5D) Questionnaire Responses | 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." | Count of Participants | Participants |
|
| EQ-5D Visual Analogue Scale (VAS) Score | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better health-related quality of life (HRQL). 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Increased scores correspond to better health state. | Mean | Standard Deviation | units on a scale |
|
| Hidradenitis Suppurativa Impact Assessment (HSIA) Overall Score | 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). | Mean | Standard Deviation | percent of maximum HS impact |
|
| WPAI-SHP: Work Time Missed Due to Health Problem | The Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) questionnaire is a 6-item questionnaire used to assess work and activity impairment due to symptoms of HS. Work time missed is 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, using the formula Q2/(Q2+Q4) and converted to percent. Higher numbers indicate greater impairment and less productivity. | Participants who were employed at Baseline and had an assessment. | Mean | Standard Deviation | percent of work time missed |
|
| WPAI-SHP: Impairment While Working Due to Health Problem | WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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), using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. | Participants who were employed at Baseline and had an assessment. | Mean | Standard Deviation | percent of impairment while working |
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| WPAI-SHP: Overall Work Impairment Due to Health Problem | WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. Calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days; (Q4) the number of actual work hours in the past 7 days; and (Q5) to what degree did the disease impair the productivity while working past 7 days, 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. | Participants who were employed at Baseline and had an assessment. | Mean | Standard Deviation | percent of overall work impairment |
|
| WPAI:SHP: Overall Activity Impairment Due to Health Problem | WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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, measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working), using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. | Participants who were employed at Baseline and had an assessment. | Mean | Standard Deviation | percent of impairment of activity |
|
| WPAI:SHP: Overall Activity Impairment Due to Health Problem: Participants Not Employed at Baseline | WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. 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, measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working), using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity. | Participants who were not employed at Baseline and had an assessment. | Mean | Standard Deviation | percent of impairment of activity |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| Secondary | 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." | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4. | Posted | Count of Participants | Participants | Baseline, Week 4 |
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| Secondary | 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." | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | 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." | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24. | Posted | Count of Participants | Participants | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | 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). | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4. | Posted | Mean | Standard Deviation | percent of maximum HS impact | Baseline, Week 4 |
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| Secondary | 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). | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of maximum HS impact | Baseline, Week 12 |
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| Secondary | 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). | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24. | Posted | Mean | Standard Deviation | percent of maximum HS impact | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with a Week 4 assessment. | Posted | Mean | Standard Deviation | percent of work time missed | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of work time missed | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 24. | Posted | Mean | Standard Deviation | percent of work time missed | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4. | Posted | Mean | Standard Deviation | percent of impairment while working | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of impairment while working | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24. | Posted | Mean | Standard Deviation | percent of impairment while working | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4. | Posted | Mean | Standard Deviation | percent of overall work impairment | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of overall work impairment | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24. | Posted | Mean | Standard Deviation | percent of overall work impairment | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline at Week 4. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline assessed at Week 24. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 24 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 4. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 4 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 12. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 12 |
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| Secondary | 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. | Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 24. | Posted | Mean | Standard Deviation | percent of impairment of activity | Baseline, Week 24 |
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| Secondary | 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:
| Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Observed cases with an assessment at given time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4, 12 and 24 |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| paired t-test |
| 0.0006 |
| Superiority |
| paired t-test |
| 0.0016 |
| Superiority |
| paired t-test |
| 0.0094 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Self-Care: Some Problems |
|
| Usual Activities: No Problems |
|
| Usual Activities: Some Problems |
|
| Usual Activities: Unable to Perform |
|
| Pain/Discomfort: None |
|
| Pain/Discomfort: Moderate |
|
| Pain/Discomfort: Extreme |
|
| Anxiety/Depression: None |
|
| Anxiety/Depression: Moderate |
|
| Anxiety/Depression: Severe |
|
| Title | Measurements |
|---|---|
|
| Self-Care: Some Problems |
|
| Usual Activities: No Problems |
|
| Usual Activities: Some Problems |
|
| Usual Activities: Unable to Perform |
|
| Pain/Discomfort: None |
|
| Pain/Discomfort: Moderate |
|
| Pain/Discomfort: Extreme |
|
| Anxiety/Depression: None |
|
| Anxiety/Depression: Moderate |
|
| Anxiety/Depression: Severe |
|
| Title | Measurements |
|---|---|
|
| Self-Care: Some Problems |
|
| Usual Activities: No Problems |
|
| Usual Activities: Some Problems |
|
| Usual Activities: Unable to Perform |
|
| Pain/Discomfort: None |
|
| Pain/Discomfort: Moderate |
|
| Pain/Discomfort: Extreme |
|
| Anxiety/Depression: None |
|
| Anxiety/Depression: Moderate |
|
| Anxiety/Depression: Severe |
|
|
| Week 24 |
|
|