Recruiting
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 - IM011-054
Mis à jour: 19 avril, 2024 | ClinicalTrials.gov
Phase
Sexe(s)
Tranche d’âge
Emplacement(s)
Recruiting
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 - ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading 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
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Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
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