Skip to main content

Table 2 Key inclusion and exclusion criteria

From: The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial

Inclusion criteria

Exclusion criteria

Age ≥18 years

Other inflammatory diseases, including:

 • rheumatoid arthritis

 • axial spondyloarthritis

 • systemic lupus erythematosus

 • Lyme disease

Active PsA despite previous csDMARD, NSAID, and/or apremilast, and/or NSAID therapy

Diagnosis of PsA for ≥6 months prior to first administration of study intervention and meeting CASPAR criteria at screening

Previous biologic therapy for PsA or psoriasis

Prior therapy with systemic immunosuppressants or apremilast within 4 weeks of study agent administration

Active PsA:

 • ≥3 swollen joints

 • ≥3 tender joints

 • CRP ≥0.3 mg/dL

Currently receiving ≥3 csDMARDs

≥2 joints with erosions on baseline radiographs of the hands and feet as determined by central read (2 readers and adjudicator if needed)

≥1 of the following PsA subtypes:

 • distal interphalangeal joint involvement

 • polyarticular arthritis with absence of rheumatoid nodules

 • asymmetric peripheral arthritis

 • spondylitis with peripheral arthritis

Active plaque psoriasis (≥1 plaque of ≥2 cm diameter and/or psoriatic nail changes)

  1. CASPAR Classification Criteria for Psoriatic Arthritis, CRP C-reactive protein, csDMARD conventional synthetic disease-modifying antirheumatic drug, NSAID nonsteroidal anti-inflammatory drug, PsA psoriatic arthritis