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.
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
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 group | Role | What they receive |
|---|---|---|
| Participants receiving adalimumab | Participants with Psoriasis receiving adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted4 Apr 2017
- Study start31 Mar 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Outcome of Psoriasis Patients in Korea on Adalimumab
- ClinicalTrials.gov ID
- NCT03099083
- Acronym / sponsor ID
- RAPSODI / P16-346
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Adalimumab, Humira, Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving adalimumab | – | –Participants with Psoriasis receiving adalimumab |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Psoriasis receiving adalimumab in Korea.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in EuroQol 5 dimension (EQ-5D) score up to week 24
Time frame: From Week 0 (baseline) to 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.
10 secondary outcomes
Change in EuroQol 5 dimension (EQ-5D) score up to week 16
Time frame: From Week 0 (baseline) to 16
Change in PASI score
Time frame: Week 0 (baseline), Week 16, and Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90
Time frame: Up to Week 24
Change in EQ-5D Visual Analogue Scale (VAS)
Time frame: Week 0 (baseline), Week 16, Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75
Time frame: Up to Week 24
Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis
Time frame: Week 0 (baseline), Week 16, Week 24
Change in Short Form (36) Health Survey (SF-36) domain scales
Time frame: Week 0 (baseline), Week 16, Week 24
Change in Dermatology Life Quality Index (DLQI)
Time frame: Week 0 (baseline), Week 16, Week 24
Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100
Time frame: Up to Week 24
Change in subject satisfaction questions
Time frame: Week 0 (baseline), Week 16, and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 37041704Kim 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.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
12 sites in 1 country: see every site and its status.
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.