Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naive to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFa Inhibitor Treatment
- Conditions
- Psoriatic Arthritis
- Registration Number
- JPRN-jRCT2031210418
- Lead Sponsor
- owak Miroslawa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants meeting ACR20 response at week16
- Secondary Outcome Measures
Name Time Method -Change from baseline DAS28-CRP [ Time Frame: At week 16 ]<br>-Change from baseline HAQ-DI [ Time Frame: At week 16 ]<br>-Proportion of participants meeting ACR20/50/70 response[ Time Frame: Up to 16 weeks ]<br>-Proportion of participants meeting PASI 75/90/100 response [ Time Frame: Up to 16 weeks ]<br>-Incidence of AEs/SAEs [Time Frame: Up to Week 52 ]