A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic… (NCT04929210) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
United States411 participantsStarted 2021-08-30
Plain-language summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 rheuma…
What they're measuring
1
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24