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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02739828
Other study ID # P15-692
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 7, 2016
Est. completion date March 28, 2018

Study information

Verified date May 2018
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 28, 2018
Est. primary completion date March 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Adalimumab
Adalimumab

Locations

Country Name City State
Sweden Hallands Hospital Halmstad Halmstad
Sweden Blekinge Hospital Karlskrona
Sweden Universitetssjukhuset Linköping Linkoping Vastra Gotalands Lan
Sweden Skaraborgs Hospital Skovde
Sweden Karolinska Univ Sjukhuset Solna
Sweden Danderyd Hospital Stockholm
Sweden Kungsholmens Hudklinik Stockholm
Sweden Sodersjukhuset Stockholm
Sweden Trelleborg Hospital Trelleborg
Sweden Norrlands Universitetssjukhus Umeå
Sweden Akademiska sjukhuset Uppsala

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
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. Baseline, Week 12
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. Baseline, Week 4
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. Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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." Baseline, Week 4
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." Baseline, Week 12
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." Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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). Baseline, Week 4
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). Baseline, Week 12
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). Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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. Baseline, Week 4
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. Baseline, Week 12
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. Baseline, Week 24
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:
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.
Week 4, 12 and 24
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