A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naïve Participants with Active Psoriatic Arthritis

简要总结

主要结局

次要结局

• Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to 3 Percent and an IGA Score of Greater Than Equal to 2 at Baseline(Week 16)
• Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline(Week 16)
• Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline(Week 16)
• Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And Greater Than Equal to 2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA Greater Than Equal to 3 percent and an IGA Score of Greater Than Equal to 2 at Baseline(Week 16)
• Proportion of Participants who Achieve an ACR 50 Response at Week 16. The ACR 50 responders are participants with an improvement of Greater Than Equal to 50 percent from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patients assessment of pain VAS, patients global assessment of disease activity VAS scale, physicians global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).(Week 16)
• Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16 MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to 1; swollen joint count less than or equal to 1; psoriasis activity and severity index less than or equal to 1 or body surface area less than or equal to 3, patient pain VAS score of less than or equal to 15, patient global disease activity VAS (arthritis and psoriasis) score of less than or equal to 20, health assessment questionnaire (HAQ) score less than or equal to 0.5, and tender entheseal points less than or equal to 1.(Week 16)
• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16. The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0-no difficulty and(3-inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 - least difficulty and 3 - extreme difficulty.)
• Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16(SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100-highest level of physical functioning).)
• Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).(From baseline to Week 16)
• Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 The FACIT-fatigue is a self-administered, 13 item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 -not at all to 4 -very much. The total score ranges from 0 to 52, with higher values indicating less fatigue.(From baseline to Week 16)
• Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score, 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score greater than 0) at baseline and no enthesis (LEO score -0) at the visit (week 16).(week 16)