Clinical trial NCT03099083: Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab
Official title: Real-World Outcome of Psoriasis Patients in Korea on Adalimumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Adalimumab
Humira
Korea
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 97
Sex: ALL
Minimum age (years): 19
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: Participants with Psoriasis receiving adalimumab in Korea.

Brief summary: The objective of this non-interventional, observational study is to assess the effect of adalimumab on health-related quality of life in participants with Psoriasis in Korea.


Eligibility criteria: Inclusion Criteria:

* Participant has a diagnosis of Psoriasis by investigator.
* Participant (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
* Participant must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

* Participants who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
* Participation in any Psoriasis-related clinical trial at the time of enrolment, at baseline or at any point during the study period.
* Participants, who in the investigator's view, may not be able to accurately report their questionnaires

Primary outcomes:
measure: Change in EuroQol 5 dimension (EQ-5D) score up to week 24
timeFrame: From Week 0 (baseline) to 24
Secondary outcomes:
measure: Change in EuroQol 5 dimension (EQ-5D) score up to week 16
timeFrame: From Week 0 (baseline) to 16
measure: Change in PASI score
timeFrame: Week 0 (baseline), Week 16, and Week 24
measure: Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90
timeFrame: Up to Week 24
measure: Change in EQ-5D Visual Analogue Scale (VAS)
timeFrame: Week 0 (baseline), Week 16, Week 24
measure: Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75
timeFrame: Up to Week 24
measure: Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis
timeFrame: Week 0 (baseline), Week 16, Week 24
measure: Change in Short Form (36) Health Survey (SF-36) domain scales
timeFrame: Week 0 (baseline), Week 16, Week 24
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Week 0 (baseline), Week 16, Week 24
measure: Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100
timeFrame: Up to Week 24
measure: Change in subject satisfaction questions
timeFrame: Week 0 (baseline), Week 16, and Week 24
Other outcomes:
Locations:
city: Anyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital /ID# 161697
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical center, CHA University /ID# 161696
state: Gyeonggido
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 161698
state: Gyeonggido
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital /ID# 166300
state: Seoul Teugbyeolsi
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospi /ID# 169553
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Busan National University Hosp /ID# 166299
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hos /ID# 166302
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hosp /ID# 161695
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hosp /ID# 161699
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital /ID# 161694
city: Seoul
country: Korea, Republic of
facility: National Medical Center /ID# 166298
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik H /ID# 166301
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: