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

  Purpose

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
Psoriasis

Study Type: Observational
Study Design:Observational Model: Cohort
Time Perspective: Prospective
Official Title:Real-World Outcome of Psoriasis Patients in Korea on Adalimumab

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:

  • 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 for the EQ-5D is approximately 2-3 minutes.

Secondary Outcome Measures:

  • 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 for the EQ-5D is approximately 2-3 minutes.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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).

  • 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.

Estimated Enrollment:100
Actual Study Start Date:March 31, 2017
Estimated Study Completion Date:November 1, 2018
Estimated Primary Completion Date:November 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants receiving adalimumab

Participants with Psoriasis receiving adalimumab

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