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Активно (без набиране) Фаза 3 NCT04908189

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 or Had Previously Received TNFα Inhibitor Treatment

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriatic Arthritis

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy 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 (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 * 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
Места на провеждане 18
Argentina (1)
Local Institution - 0048
La Plata , Buenos Aires
Австралия (1)
Local Institution - 0003
Botany , New South Wales
Белгия (1)
Local Institution - 0078
Brussels
Канада (1)
Local Institution - 0111
Vancouver , British Columbia
Китай (1)
Local Institution - 0126
Bengbu , Anhui
Colombia (1)
Local Institution - 0072
Barranquilla , Atlántico
Чехия (1)
Local Institution - 0010
Brno
Германия (1)
Local Institution - 0176
Ratingen , North Rhine-Westphalia
Унгария (1)
Local Institution - 0025
Veszprém , Veszprém City
Италия (1)
Azienda Ospedaliera Universitaria Careggi-Reumatologia
Florence
Япония (1)
Local Institution - 0202
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0052
León , Guanajuato
Полша (1)
Local Institution - 0082
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Russia (1)
Local Institution
Moscow
Испания (1)
Local Institution - 0014
Barcelona
Taiwan (1)
Local Institution - 0090
Taichung
Великобритания (1)
Local Institution - 0185
London , England
САЩ (1)
Local Institution - 0149
Mountain Brook , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
15.07.2021
Крайна дата
12.11.2026
Регистрационен номер
NCT04908189
Източник
anzctr
Запитване за медицински туризъм

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