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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04908189
Registration number
NCT04908189
Ethics application status
Date submitted
28/05/2021
Date registered
1/06/2021
Date last updated
13/06/2025
Titles & IDs
Public title
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFa Inhibitor Treatment
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Scientific title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFa Inhibitor Treatment
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Secondary ID [1]
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2020-005099-36
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Secondary ID [2]
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IM011-055
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Other interventions - Placebo
Treatment: Drugs - Apremilast
Experimental: Deucravacitinib -
Placebo comparator: Placebo -
Other: Apremilast -
Treatment: Drugs: Deucravacitinib
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
Treatment: Drugs: Apremilast
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
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Assessment method [1]
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The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
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Assessment method [1]
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DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
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Timepoint [1]
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Baseline, Week 16
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Secondary outcome [2]
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Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
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Assessment method [2]
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HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
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Timepoint [2]
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Baseline, Week 16
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Secondary outcome [3]
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Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
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Assessment method [3]
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PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
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Assessment method [4]
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SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [5]
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Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
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Assessment method [5]
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Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
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Timepoint [5]
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0
Week 16
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Secondary outcome [6]
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Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
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Assessment method [6]
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Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count = 1 2. Swollen joint count = 1 3. Psoriasis Area and Severity Index (PASI) = 1 or body surface area (BSA) = 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain = 15 5. Patient Global Assessment of PsA disease activity = 20 6. HAQ-DI = 0.5 7. Tender enthesial points = 1
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
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Assessment method [7]
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FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
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Timepoint [7]
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Baseline, Week 16
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Secondary outcome [8]
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Number of Participants Meeting Dactylitis Resolution at Week 16
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Assessment method [8]
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Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count = 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
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Assessment method [9]
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The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
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Assessment method [10]
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0
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [10]
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0
Week 16
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Secondary outcome [11]
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0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
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Assessment method [11]
0
0
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
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Timepoint [11]
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Baseline, Weeks 2, 4, 8, 12, 16
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Secondary outcome [12]
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Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
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Assessment method [12]
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Number of participants who achieve a clinically meaningful improvement (= 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score = 0.35 at baseline. HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered.
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Timepoint [12]
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0
Week 16
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Secondary outcome [13]
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Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
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Assessment method [13]
0
0
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [13]
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0
Weeks 4, 8, 12, 16
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Secondary outcome [14]
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Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
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Assessment method [14]
0
0
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [14]
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0
Weeks 4, 8, 12, 16
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Secondary outcome [15]
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Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
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Assessment method [15]
0
0
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
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Timepoint [15]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [16]
0
0
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
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Assessment method [16]
0
0
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
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Timepoint [16]
0
0
Baseline, Weeks 4, 12, 16
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Secondary outcome [17]
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0
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
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Assessment method [17]
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Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
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Timepoint [17]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [18]
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Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
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Assessment method [18]
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Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \[R\]/left \[L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
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Timepoint [18]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [19]
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Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
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Assessment method [19]
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Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count = 1 2. Swollen joint count = 1 3. Psoriasis Area and Severity Index (PASI) = 1 or body surface area (BSA) = 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain = 15 5. Patient Global Assessment of PsA disease activity = 20 6. HAQ-DI = 0.5 7. Tender enthesial points = 1
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Timepoint [19]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [20]
0
0
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
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Assessment method [20]
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0
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
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Timepoint [20]
0
0
Baseline, Weeks 4, 12, 16
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Secondary outcome [21]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
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Assessment method [21]
0
0
FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
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Timepoint [21]
0
0
Baseline, Weeks 2, 4, 8, 12, 16
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Secondary outcome [22]
0
0
Number of Participants Meeting Dactylitis Resolution
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Assessment method [22]
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0
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count = 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
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Timepoint [22]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [23]
0
0
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
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Assessment method [23]
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The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
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Timepoint [23]
0
0
Baseline, Weeks 2, 4, 8, 12, 16
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Secondary outcome [24]
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0
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
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Assessment method [24]
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0
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
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Timepoint [24]
0
0
Baseline, Weeks 2, 4, 8, 12, 16
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Secondary outcome [25]
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0
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
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Assessment method [25]
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0
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
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Timepoint [25]
0
0
Weeks 2, 4, 8, 12, 16
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Secondary outcome [26]
0
0
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
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Assessment method [26]
0
0
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
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Timepoint [26]
0
0
Weeks 2, 4, 8, 12, 16
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Secondary outcome [27]
0
0
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
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Assessment method [27]
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0
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
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Timepoint [27]
0
0
Weeks 4, 8, 12, 16
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Secondary outcome [28]
0
0
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
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Assessment method [28]
0
0
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
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Timepoint [28]
0
0
Baseline, Weeks 2, 4, 8, 12, 16
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Secondary outcome [29]
0
0
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
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Assessment method [29]
0
0
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Query!
Timepoint [29]
0
0
Weeks 2, 4, 8, 12, 16
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Secondary outcome [30]
0
0
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
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Assessment method [30]
0
0
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: \< 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, \> 5.1: High disease activity.
Query!
Timepoint [30]
0
0
Weeks 2, 4, 8, 12, 16
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Secondary outcome [31]
0
0
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
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Assessment method [31]
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0
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Query!
Timepoint [31]
0
0
Baseline, Weeks 4, 12, 16
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Secondary outcome [32]
0
0
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
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Assessment method [32]
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0
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Query!
Timepoint [32]
0
0
Baseline, Weeks 4, 8, 12, 16
Query!
Secondary outcome [33]
0
0
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Query!
Assessment method [33]
0
0
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of = 30% in tender joint counts; 2) Decrease of = 30% in swollen joint counts; 3) Decrease of = 20% in Physician Global Assessment of PsA; 4) Decrease of = 20% in Participant's Global Assessment of Disease Activity
Query!
Timepoint [33]
0
0
Weeks 2, 4, 8, 12, 16
Query!
Secondary outcome [34]
0
0
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Query!
Assessment method [34]
0
0
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Query!
Timepoint [34]
0
0
Weeks 2, 4, 8, 12, 16
Query!
Secondary outcome [35]
0
0
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Query!
Assessment method [35]
0
0
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Query!
Timepoint [35]
0
0
Baseline, Week 16
Query!
Secondary outcome [36]
0
0
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Query!
Assessment method [36]
0
0
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Query!
Timepoint [36]
0
0
Baseline, Weeks 4, 16
Query!
Secondary outcome [37]
0
0
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Query!
Assessment method [37]
0
0
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Query!
Timepoint [37]
0
0
Baseline, Weeks 4, 12, 16
Query!
Eligibility
Key inclusion criteria
* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
* Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
* Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
* Active arthritis as shown by = 3 swollen joints and = 3 tender joints at Screening and Day 1
* Participant has high sensitivity C-reactive protein (hsCRP) = 3 mg/L at Screening
* Must have completed the week 52 treatment for the optional open-label long-term extension period
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Nonplaque psoriasis at Screening or Day 1
* Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
* History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
* Active fibromyalgia
* Received an approved or investigational biologic therapy for the treatment of PsA or PsO
Other protocol-defined inclusion/exclusion criteria apply
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
15/07/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
12/11/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
729
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - 0003 - Botany
Query!
Recruitment hospital [2]
0
0
Local Institution - 0018 - Paramatta
Query!
Recruitment hospital [3]
0
0
Local Institution - 0004 - Maroochydore
Query!
Recruitment hospital [4]
0
0
Local Institution - 0099 - Woodville
Query!
Recruitment hospital [5]
0
0
Local Institution - 0002 - Camberwell
Query!
Recruitment hospital [6]
0
0
Local Institution - 0017 - Geelong
Query!
Recruitment postcode(s) [1]
0
0
2019 - Botany
Query!
Recruitment postcode(s) [2]
0
0
2150 - Paramatta
Query!
Recruitment postcode(s) [3]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [6]
0
0
3220 - Geelong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Louisiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Maryland
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Michigan
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Minnesota
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0
0
United States of America
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State/province [9]
0
0
Mississippi
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
North Carolina
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Ohio
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oklahoma
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Oregon
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Pennsylvania
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Country [16]
0
0
United States of America
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State/province [16]
0
0
South Carolina
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Texas
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Washington
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Wisconsin
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Country [20]
0
0
Argentina
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State/province [20]
0
0
Buenos Aires
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Country [21]
0
0
Argentina
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State/province [21]
0
0
Distrito Federal
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Country [22]
0
0
Argentina
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State/province [22]
0
0
Tucuman
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Country [23]
0
0
Belgium
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State/province [23]
0
0
Brussels
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Country [24]
0
0
Belgium
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State/province [24]
0
0
Gent
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Country [25]
0
0
Belgium
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State/province [25]
0
0
Liège
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Country [26]
0
0
Canada
Query!
State/province [26]
0
0
British Columbia
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
China
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State/province [29]
0
0
Anhui
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Country [30]
0
0
China
Query!
State/province [30]
0
0
Beijing
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Country [31]
0
0
China
Query!
State/province [31]
0
0
Guangdong
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Henan
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Hunan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Jiangsu
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Jiangxi
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Neimeng
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Shan3xi
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shanghai
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Sichuan
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Xinjiang
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Yunnan
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Zhejiang
Query!
Country [43]
0
0
Colombia
Query!
State/province [43]
0
0
Atlántico
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Bogotá
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Cali
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Chía
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Medellin
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Brno
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Ostrava
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Praha 2
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Uherske Hradiste
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Nordrhein-Westfalen
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Erlangen
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Hamburg
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Köln
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Magdeburg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Minden
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Tübingen
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Veszprém City
Query!
Country [60]
0
0
Hungary
Query!
State/province [60]
0
0
Budapest
Query!
Country [61]
0
0
Hungary
Query!
State/province [61]
0
0
Debrecen
Query!
Country [62]
0
0
Hungary
Query!
State/province [62]
0
0
Gyula
Query!
Country [63]
0
0
Hungary
Query!
State/province [63]
0
0
Hódmezovásárhely
Query!
Country [64]
0
0
Hungary
Query!
State/province [64]
0
0
Kistarcsa
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Firenze
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Potenza
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Roma
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Aichi
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Hokkaido
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
MIE
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Osaka
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Tokyo
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Fukuoka
Query!
Country [74]
0
0
Mexico
Query!
State/province [74]
0
0
Distrito Federal
Query!
Country [75]
0
0
Mexico
Query!
State/province [75]
0
0
Guanajuato
Query!
Country [76]
0
0
Mexico
Query!
State/province [76]
0
0
Jalisco
Query!
Country [77]
0
0
Mexico
Query!
State/province [77]
0
0
Yucatan
Query!
Country [78]
0
0
Mexico
Query!
State/province [78]
0
0
Chihuahua
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Kujawsko-pomorskie
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Mazowieckie
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Pomorskie
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Elblag
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Torun
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Wroclaw
Query!
Country [85]
0
0
Russian Federation
Query!
State/province [85]
0
0
Moscow
Query!
Country [86]
0
0
Russian Federation
Query!
State/province [86]
0
0
Novosibirsk
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Barcelona
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Madrid
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Santander
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
València
Query!
Country [91]
0
0
Taiwan
Query!
State/province [91]
0
0
Taichung City
Query!
Country [92]
0
0
Taiwan
Query!
State/province [92]
0
0
Taichung
Query!
Country [93]
0
0
Taiwan
Query!
State/province [93]
0
0
Taipei
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
England
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Bradford
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Hull
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Liverpool
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Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
London
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Country [99]
0
0
United Kingdom
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State/province [99]
0
0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFa inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04908189
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/89/NCT04908189/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/89/NCT04908189/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04908189
Download to PDF