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PsoriasisRAPSODINCT03099083

Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab

An observational study of Psoriasis, run by AbbVie at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 99 years
Conditions the study is for
Psoriasis
How many people
97 participants
Where
12 sitesSouth Korea
Study dates
31 Mar 2017to 5 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with Psoriasis receiving adalimumab in Korea.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites
  • Hallym University Sacred Heart Hospital /ID# 161697

    Anyang-si, Gyeonggi-do, Gyeonggido, 14068

  • Busan National University Hosp /ID# 166299

    Busan, 602-739

  • Inje University Ilsan Paik Hos /ID# 166302

    Goyang, 411-706

  • Korea University Ansan Hosp /ID# 161695

    Gyeonggi-do, 152-703

  • Korea University Ansan Hosp /ID# 161699

    Gyeonggi-do, 152-703

  • Yonsei University Health System, Severance Hospital /ID# 166300

    Seodaemun-gu, Seoul Teugbyeolsi, 03722

  • Hanyang University Seoul Hospi /ID# 169553

    Seongdong-gu, Seoul Teugbyeolsi, 04763

  • CHA Bundang Medical center, CHA University /ID# 161696

    Seongnam-si, Gyeonggido, 13496

  • Kyunghee University Hospital /ID# 161694

    Seoul, 02447

  • National Medical Center /ID# 166298

    Seoul, 100-799

  • Inje University Sanggye Paik H /ID# 166301

    Seoul, 139-707

  • Ajou University Hospital /ID# 161698

    Suwon, Gyeonggido, 16499

Other trials in South Korea

About this study

Official title: Real-World Outcome of Psoriasis Patients in Korea on Adalimumab

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.

Conditions
Psoriasis
Keywords
Psoriasis, Adalimumab, Humira, Korea
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03099083
Study groupRoleWhat they receive
Participants receiving adalimumabParticipants with Psoriasis receiving adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Week 0 (baseline) to 24

Secondary outcomes (10)
  1. Change in EuroQol 5 dimension (EQ-5D) score up to week 16

    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.

    Measured: From Week 0 (baseline) to 16

  2. Change in PASI score

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).

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

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

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-90 responders are the participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24.

    Measured: Up to Week 24

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

    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. In addition, a VAS rates current health state between 0-100. The EQ-5D results can be converted to health utility scores. Completion time for the EQ-5D is approximately 2-3 minutes.

    Measured: Week 0 (baseline), Week 16, Week 24

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

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24.

    Measured: Up to Week 24

  6. Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis

    NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.

    Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:

    • 0 = none;
    • 1 = present in 1/4 nail quadrants;
    • 2 = present in 2/4 nail quadrants;
    • 3 = present in 3/4 nail quadrants;
    • 4 = present in 4/4 nail quadrants.

    The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants).

    Measured: Week 0 (baseline), Week 16, Week 24

  7. Change in Short Form (36) Health Survey (SF-36) domain scales

    The SF-36 is a subject-reported questionnaire of subject health-related QoL. It measures generic health concepts relevant across age, disease, and treatment groups. There are 36 items in total and the recall period is the last 4 weeks. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Completion time for the SF-36 is approximately 10 minutes.

    Measured: Week 0 (baseline), Week 16, Week 24

  8. Change in Dermatology Life Quality Index (DLQI)

    The DLQI is developed as a simple, concise, practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with subjects' self-assessments of how their Psoriasis has affected their everyday lives during the latest 7-day period. The DLQI score ranges from 0-30, with 0 corresponding to the best quality of life and 30 the worst. The DLQI has well established properties of reliability and validity when used in a dermatology clinical practice setting.

    Measured: Week 0 (baseline), Week 16, Week 24

  9. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100

    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-100 responders are the participants who achieved at least a 100% reduction (improvement) from baseline in PASI score at Week 24.

    Measured: Up to Week 24

  10. Change in subject satisfaction questions

    The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start31 Mar 2017
  3. Primary completion5 Apr 2019
  4. Study completion5 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099083
Sponsor's protocol ID
P16-346
Acronym
RAPSODI
Status last verified
Apr 2019
First submitted
29 Mar 2017
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37041704

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis, run by AbbVie at 12 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EuroQol 5 dimension (EQ-5D) score up to week 24 (time frame: From Week 0 (baseline) to 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.

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