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Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab (RAPSODI)

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ClinicalTrials.gov Identifier: NCT03099083
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease
Psoriasis

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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real-World Outcome of Psoriasis Patients in Korea on Adalimumab
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Group/Cohort
Participants receiving adalimumab
Participants with Psoriasis receiving adalimumab



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in EuroQol 5 dimension (EQ-5D) score up to week 16 [ Time Frame: From Week 0 (baseline) to 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.

  2. Change in PASI score [ Time Frame: Week 0 (baseline), Week 16, and Week 24 ]
    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).

  3. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 90 [ Time Frame: Up to Week 24 ]
    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.

  4. Change in EQ-5D Visual Analogue Scale (VAS) [ Time Frame: Week 0 (baseline), Week 16, 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. 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.

  5. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Up to Week 24 ]
    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.

  6. Change in Nail Psoriasis Severity Index (NAPSI) score in participants with nail psoriasis [ Time Frame: Week 0 (baseline), Week 16, Week 24 ]

    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).


  7. Change in Short Form (36) Health Survey (SF-36) domain scales [ Time Frame: Week 0 (baseline), Week 16, Week 24 ]
    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.

  8. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: Week 0 (baseline), Week 16, Week 24 ]
    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.

  9. Percentage of participants achieving Psoriasis Area and Severity Index (PASI) 100 [ Time Frame: Up to Week 24 ]
    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.

  10. Change in subject satisfaction questions [ Time Frame: Week 0 (baseline), Week 16, and Week 24 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Psoriasis receiving adalimumab in Korea.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099083


Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital /ID# 161697
Anyang-si, Gyeonggi-do, Gyeonggido, Korea, Republic of, 14068
CHA Bundang Medical center, CHA University /ID# 161696
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Ajou University Hospital /ID# 161698
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Yonsei University Health System, Severance Hospital /ID# 166300
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Hanyang University Seoul Hospi /ID# 169553
Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of, 04763
Busan National University Hosp /ID# 166299
Busan, Korea, Republic of, 602-739
Inje University Ilsan Paik Hos /ID# 166302
Goyang, Korea, Republic of, 411-706
Korea University Ansan Hosp /ID# 161695
Gyeonggi-do, Korea, Republic of, 152-703
Korea University Ansan Hosp /ID# 161699
Gyeonggi-do, Korea, Republic of, 152-703
Kyunghee University Hospital /ID# 161694
Seoul, Korea, Republic of, 02447
National Medical Center /ID# 166298
Seoul, Korea, Republic of, 100-799
Inje University Sanggye Paik H /ID# 166301
Seoul, Korea, Republic of, 139-707
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03099083    
Other Study ID Numbers: P16-346
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Psoriasis
Adalimumab
Humira
Korea
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases