Clinical trial NCT02739828: Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients
Official title: Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients With Moderate or Severe Hidradenitis Suppurativa (HS) After 6 Months on Adalimumab Treatment (HOPE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Keywords: Quality of life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with moderate or severe Hidradenitis Suppurativa

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in DLQI at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in DLQI at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in DLQI at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24
timeFrame: Baseline, Week 24
measure: EQ-5D Questionnaire Responses at Week 4
timeFrame: Baseline, Week 4
measure: EQ-5D Questionnaire Responses at Week 12
timeFrame: Baseline, Week 12
measure: EQ-5D Questionnaire Responses at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in EQ-5D VAS Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in EQ-5D VAS Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in EQ-5D VAS Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in HSIA Overall Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in HSIA Overall Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in HSIA Overall Score at Week 24
timeFrame: Baseline, Week 24
measure: WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4
timeFrame: Baseline, Week 4
measure: WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12
timeFrame: Baseline, Week 12
measure: WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24
timeFrame: Baseline, Week 24
measure: WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4
timeFrame: Baseline, Week 4
measure: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4
timeFrame: Baseline, Week 4
measure: Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4
timeFrame: Baseline, Week 4
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline
timeFrame: Baseline, Week 4
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline
timeFrame: Baseline, Week 24
measure: Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time
timeFrame: Week 4, 12 and 24
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Universitetssjukhuset Linköping
state: Vastra Gotalands Lan
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
city: Karlskrona
country: Sweden
facility: Blekinge Hospital
city: Skovde
country: Sweden
facility: Skaraborgs Hospital
city: Solna
country: Sweden
facility: Karolinska Univ Sjukhuset
city: Stockholm
country: Sweden
facility: Kungsholmens Hudklinik
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Trelleborg
country: Sweden
facility: Trelleborg Hospital
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: