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
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Psoriatic Arthritis
Спонсор: Bristol-Myers Squibb
Налично на:
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Обобщение
The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.
Кой може да участва
Inclusion Criteria
* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
* Meets the Classification Criteria for Psoriatic Arthritis 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.
* ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
* Must have completed the week 52 treatment for the optional open-label long-term extension period.
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.
Интервенции
Deucravacitinib
DRUG
Placebo
OTHER
Места на провеждане
183
Argentina (10)
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Ciudad Autónoma de Buenos Aires , Buenos Aires
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Córdoba , Córdoba Province
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La Plata , Buenos Aires
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Mendoza
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Quilmes , Buenos Aires
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Rosario , Santa Fe Province
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San Miguel de Tucumán , Tucumán Province
Австралия (6)
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Botany , New South Wales
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Camberwell , Victoria
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Hobart , Tasmania
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Phillip , Australian Capital Territory
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Westmead , New South Wales
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Woolloongabba , Queensland
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Salvador , Estado de Bahia
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Santo André , São Paulo
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България (10)
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Varna
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Mexico City
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