NCT03099083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

March 30, 2020

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

March 29, 2017

Last Update Submit

March 27, 2020

Conditions

Psoriasis

Keywords

PsoriasisAdalimumabHumiraKorea

Outcome Measures

Primary Outcomes (1)

  • Change in EuroQol 5 dimension (EQ-5D) score up to week 24

    The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.

    From Week 0 (baseline) to 24

Secondary Outcomes (10)

  • Change in EuroQol 5 dimension (EQ-5D) score up to week 16

    From Week 0 (baseline) to 16

  • Change in PASI score

    Week 0 (baseline), Week 16, and Week 24

  • Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90

    Up to Week 24

  • Change in EQ-5D Visual Analogue Scale (VAS)

    Week 0 (baseline), Week 16, Week 24

  • Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75

    Up to Week 24

  • +5 more secondary outcomes

Study Arms (1)

Participants receiving adalimumab

Participants with Psoriasis receiving adalimumab

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with Psoriasis receiving adalimumab in Korea.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hallym University Sacred Heart Hospital /ID# 161697

Anyang-si, Gyeonggi-do, Gyeonggido, 14068, South Korea

Location

CHA Bundang Medical center, CHA University /ID# 161696

Seongnam-si, Gyeonggido, 13496, South Korea

Location

Ajou University Hospital /ID# 161698

Suwon, Gyeonggido, 16499, South Korea

Location

Yonsei University Health System, Severance Hospital /ID# 166300

Seodaemun-gu, Seoul Teugbyeolsi, 03722, South Korea

Location

Hanyang University Seoul Hospi /ID# 169553

Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea

Location

Busan National University Hosp /ID# 166299

Busan, 602-739, South Korea

Location

Inje University Ilsan Paik Hos /ID# 166302

Goyang, 411-706, South Korea

Location

Korea University Ansan Hosp /ID# 161695

Gyeonggi-do, 152-703, South Korea

Location

Korea University Ansan Hosp /ID# 161699

Gyeonggi-do, 152-703, South Korea

Location

Kyunghee University Hospital /ID# 161694

Seoul, 02447, South Korea

Location

National Medical Center /ID# 166298

Seoul, 100-799, South Korea

Location

Inje University Sanggye Paik H /ID# 166301

Seoul, 139-707, South Korea

Location

Related Publications (1)

  • Kim DH, Son SW, Jeong KH, Ahn J, Lee ES, Kim IH, Lee UH, Park HJ, Ko JY, Kim BS, Kim JJ, Rashid J, Kim KJ. Real-World Outcomes of Adalimumab Treatment for Moderate and Severe Psoriasis in Korean Patients (RAPSODI Study). Ann Dermatol. 2023 Apr;35(2):107-115. doi: 10.5021/ad.22.041.

    PMID: 37041704DERIVED

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

March 31, 2017

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

March 30, 2020

Record last verified: 2019-04

Locations

KR(12)