Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab

Psoriasis Clinical Trial

— RAPSODI  

Official title:

Real-World Outcome of Psoriasis Patients in Korea on Adalimumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099083
• Other study ID #: P16-346
• Status: Completed
• Start date: March 31, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital /ID# 161697	Anyang-si, Gyeonggi-do	Gyeonggido
Korea, Republic of	Busan National University Hosp /ID# 166299	Busan
Korea, Republic of	Inje University Ilsan Paik Hos /ID# 166302	Goyang
Korea, Republic of	Korea University Ansan Hosp /ID# 161695	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hosp /ID# 161699	Gyeonggi-do
Korea, Republic of	Yonsei University Health System, Severance Hospital /ID# 166300	Seodaemun-gu	Seoul Teugbyeolsi
Korea, Republic of	Hanyang University Seoul Hospi /ID# 169553	Seongdong-gu	Seoul Teugbyeolsi
Korea, Republic of	CHA Bundang Medical center, CHA University /ID# 161696	Seongnam-si	Gyeonggido
Korea, Republic of	Inje University Sanggye Paik H /ID# 166301	Seoul
Korea, Republic of	Kyunghee University Hospital /ID# 161694	Seoul
Korea, Republic of	National Medical Center /ID# 166298	Seoul
Korea, Republic of	Ajou University Hospital /ID# 161698	Suwon-si	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From Week 0 (baseline) to 16
Secondary	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).	Week 0 (baseline), Week 16, and Week 24
Secondary	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.	Up to Week 24
Secondary	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.	Week 0 (baseline), Week 16, Week 24
Secondary	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.	Up to Week 24
Secondary	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).	Week 0 (baseline), Week 16, Week 24
Secondary	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.	Week 0 (baseline), Week 16, Week 24
Secondary	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.	Week 0 (baseline), Week 16, Week 24
Secondary	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.	Up to Week 24
Secondary	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.	Week 0 (baseline), Week 16, and Week 24

External Links

•   clinical study report synopsis