Anti-Inflammatory Effects of Time-Restricted Feeding
NCT04728165
Psoriasis, Skin Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT03099083
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.
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Notify Me19 year–99 year
All sexes
Observational
Hallym University Sacred Heart Hospital /ID# 161697, Anyang-si, Gyeonggi-do, Gyeonggido, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
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:
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).
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.
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.
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.
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.
AbbVie
Industry
Real-World Outcome of Psoriasis Patients in Korea on Adalimumab
Acronym: RAPSODI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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