Efficacy and safety of guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial

Table 3 Key inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Age ≥ 18 years	Other inflammatory diseases (e.g., RA, AS, lupus)
Diagnosis of PsA for ≥ 6 months prior to enrolment and meet CASPAR criteria at screening	Previous biologic therapy
Active PsA: ≥ 3 swollen joints and ≥ 3 tender joints and CRP ≥ 0.3 mg/dL	Previous JAK inhibitor therapy
BASDAI ≥ 4	Prior therapy with systemic immunosuppressants; epidural, intra-articular, intramuscular, or intravenous (IV) corticosteroids, including adrenocorticotropic hormone; or apremilast within 4 weeks of study agent administration
Spinal pain VAS ≥ 4	Receiving ≥ 2 csDMARDs at baseline
Active plaque psoriasis (≥ 1 plaque of ≥ 2 cm and/or psoriatic nail changes) or documented history of psoriasis
Imaging-confirmed (centrally read) PsA axial disease (positive MRI of spine and/or SI joints, defined as a SPARCC score of ≥ 3 in either the spine or the SI joints)
Concomitant use of oral corticosteroids, NSAIDs, and/or one csDMARD was permitted at stables doses
No history of latent or active tuberculosis

AS ankylosing spondylitis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, CASPAR Classification criteria for Psoriatic Arthritis, CRP C-reactive protein, csDMARD conventional synthetic disease-modifying anti-rheumatic drug, JAK Janus Kinase, MRI magnetic resonance imaging, NSAID nonsteroidal anti-inflammatory drug, PsA psoriatic arthritis, RA rheumatoid arthritis, SI sacroiliac, SPARCC Spondyloarthritis Research Consortium of Canada, VAS visual analog scale

ISSN: 1745-6215