JRCT ID: jRCT2031210418
Registered date:09/11/2021
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
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Psoriatic Arthritis |
Date of first enrollment | 18/03/2022 |
Target sample size | 700 |
Countries of recruitment | USA,Japan,Spain,Japan,Germany,Japan,Italy,Japan,UK,Japan,Poland,Japan,Czech Republic,Japan,Russia,Japan,Hungary,Japan,Mexico,Japan,Taiwan,Japan,Argentina,Japan,China,Japan,Colombia,Japan,Belgium,Japan,Australia,Japan,Canada,Japan |
Study type | Interventional |
Intervention(s) | Drug:Deucravacitinib(BMS-986165) Specified dose on specified days,Oral |
Outcome(s)
Primary Outcome | Proportion of participants meeting ACR20 response at week16 |
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Secondary Outcome | -Change from baseline DAS28-CRP [ Time Frame: At week 16 ] -Change from baseline HAQ-DI [ Time Frame: At week 16 ] -Proportion of participants meeting ACR20/50/70 response[ Time Frame: Up to 16 weeks ] -Proportion of participants meeting PASI 75/90/100 response [ Time Frame: Up to 16 weeks ] -Incidence of AEs/SAEs [Time Frame: Up to Week 52 ] |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Nowak Miroslawa |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04908189 |
Contact
Public contact | |
Name | Miroslawa Nowak |
Address | 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-120-093-507 |
MG-JP-RCO-JRCT@bms.com | |
Affiliation | Bristol-Myers Squibb |
Scientific contact | |
Name | Miroslawa Nowak |
Address | 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-120-093-507 |
mg-jp-clinical_trial@bms.com | |
Affiliation | Bristol-Myers Squibb |