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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02739828
Date of registration:	12/04/2016
Prospective Registration:	No
Primary sponsor:	AbbVie
Public title:	Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients HOPE
Scientific 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)
Date of first enrolment:	April 7, 2016
Target sample size:	24
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02739828
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Sweden

Contacts

Name:	AbbVie Inc.
Address:
Telephone:
Email:
Affiliation:	AbbVie

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hidradenitis Suppurativa

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Change From Baseline in DLQI at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Change From Baseline in HSIA Overall Score at Week 4 [Time Frame: Baseline, Week 4]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline [Time Frame: Baseline, Week 24]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline [Time Frame: Baseline, Week 4]

WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4 [Time Frame: Baseline, Week 4]

EQ-5D Questionnaire Responses at Week 4 [Time Frame: Baseline, Week 4]

Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12 [Time Frame: Baseline, Week 12]

Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24 [Time Frame: Baseline, Week 24]

WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4 [Time Frame: Baseline, Week 4]

Change From Baseline in DLQI at Week 24 [Time Frame: Baseline, Week 24]

EQ-5D Questionnaire Responses at Week 24 [Time Frame: Baseline, Week 24]

Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time [Time Frame: Week 4, 12 and 24]

Change From Baseline in HSIA Overall Score at Week 12 [Time Frame: Baseline, Week 12]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12 [Time Frame: Baseline, Week 12]

Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in EQ-5D VAS Score at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in HSIA Overall Score at Week 24 [Time Frame: Baseline, Week 24]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24 [Time Frame: Baseline, Week 24]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4 [Time Frame: Baseline, Week 4]

Change From Baseline in DLQI at Week 4 [Time Frame: Baseline, Week 4]

Change From Baseline in EQ-5D VAS Score at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in EQ-5D VAS Score at Week 4 [Time Frame: Baseline, Week 4]

EQ-5D Questionnaire Responses at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4 [Time Frame: Baseline, Week 4]

WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12 [Time Frame: Baseline, Week 12]

WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24 [Time Frame: Baseline, Week 24]

Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline [Time Frame: Baseline, Week 12]

Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24 [Time Frame: Baseline, Week 24]

Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4 [Time Frame: Baseline, Week 4]

Secondary ID(s)

P15-692

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	09/08/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02739828

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