The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life. This study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Drug will be administered in tablet form.
Drug will be administered in tablet form.
UT Southwestern Medical Center
Dallas, Texas, United States
Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks
Proportion of patients achieving a novel composite endpoint of BSA \</= 1 AND SJC \</= 1) OR (BSA \</= 1 AND TJC \</= 1) at 24 weeks
Time frame: 24 weeks
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Time frame: baseline and weeks 5, 12, 24, and 48
Proportion of patients achieving Minimal Disease Activity (5/7 criteria) at weeks 24 and 48
Reaching Minimal Disease Activity involves achieving 5 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Minimal Disease Activity assessment will be done at weeks 24 and 48.
Time frame: weeks 24 and 48
Proportion of patients achieving Very Low Disease Activity (7/7 criteria) at weeks 24 and 48
Very Low Disease Activity involves achieving 7 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Very Low Disease Activity assessment will be done at weeks 24 and 48.
Time frame: weeks 24 and 48
Proportion of patients achieving Minimal Disease Activity - Skin (MDA with skin domain met) at weeks 24 and 48
Minimal Disease Activity - Skin is determined by a Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %. The Minimal Disease Activity - Skin assessment will be done at weeks 24 and 48.
Time frame: weeks 24 and 48
Percentage achieving Psoriatic Area and Severity Index 75/90/100, PASI < 1 BL at weeks 12, 24 and 48
75%, 90% and 100% improvement in Psoriatic Area and Severity Index of less than 1 at baseline. This assessment will be done at weeks 12, 24 and 48.
Time frame: baseline and weeks 12, 24 and 48
Percentage achieving BSA < 1% (NPF definition) BL at weeks 12, 24 and 48
Percentage achieving BSA \< 1% (NPF definition) BL at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
Resolution of Spondyloarthritis Research Consortium of Canada at baseline and at weeks 24 and 48
Resolution of Spondyloarthritis Research Consortium of Canada at baseline and at weeks 24 and 48
Time frame: baseline and weeks 24 and 48
Resolution of Leeds Enthesitis Index at baseline and at weeks 24 and 48
Resolution of Leeds Enthesitis Index at baseline and at weeks 24 and 48
Time frame: baseline and weeks 24 and 48
Change from baseline Health Assessment Questionnaire - Disability Index at weeks 24 and 48
Change from baseline Health Assessment Questionnaire - Disability Index at weeks 24 and 48
Time frame: baseline and weeks 24 and 48
Change from baseline Pruritis Numeric Rating Scale at weeks 12, 24 and 48
Change from baseline Pruritis Numeric Rating Scale at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
Change from baseline Joint pain Visual Analog Scale at weeks 12, 24 and 48
Change from baseline Joint pain Visual Analog Scale at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
Change from baseline patient global assessment of arthritis at weeks 12, 24 and 48
Change from baseline patient global assessment of arthritis at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
Change from baseline Dermatology Life Quality Index at weeks 12, 24 and 48
Change from baseline Dermatology Life Quality Index at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
Change from baseline Psoriatic Arthritis Impact of Disease 12-item Questionnaire and proportion achieving Patient Acceptable Symptom State cutoff at weeks 12, 24 and 48
Change from baseline Psoriatic Arthritis Impact of Disease 12-item Questionnaire and proportion achieving Patient Acceptable Symptom State cutoff at weeks 12, 24 and 48
Time frame: baseline and weeks 12, 24 and 48
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