Last updated 16 days ago

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

405 patients around the world
Available in Argentina
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.
Janssen Research & Development, LLC
4Research sites
405Patients around the world
This study is for people with
Arthritis
Psoriasic arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
Consultorios Reumatológicos Pampa
Consultorios Reumatológicos Pampa
Recruiting
La Pampa 1548, CABA, Buenos Aires
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Centro Privado de Medicina Familiar
Recruiting
Buenos Aires, C1417EYG
Hospital Italiano de La Plata
Recruiting
Av. 51 entre 29 y 30 Nro 1725, La Plata, Buenos Aires
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