A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants with Active Psoriatic Arthritis Axial Disease - STAR

Janssen-Cilag International NV0 个研究点目标入组 405 人开始时间: 2021年6月29日最近更新: 2024年6月10日

试验速览

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•- Be at least 18 years of age.
•- Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening.
•- Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein =0.3 mg/dL at screening from the central laboratory.
•- Have a BASDAI score of at least 4.
•- Have magnetic resonance imaging-confirmed PsA axial disease (positive MRI spine and/or SI joints, shown by a SPARCC score of =3 in either the spine or the sacroiliac joints).
•- Have a spinal pain score of at least 4.
•For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 365
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
•- Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment.
•- Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor.
•- Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention.
•- Has received apremilast within 4 weeks prior to the first administration of study intervention.
•- Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
•For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol

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