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
Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
Has previously received any biologic treatment
Has ever received a Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
Sites
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