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

Table 3 ICEs for the analyses of the primary and major secondary endpoints

1. Discontinued study intervention injections due to any reason except due to Natural Disaster or Major Disruption^a
2. Initiated or increased the dose of csDMARDs or oral corticosteroids over baseline for PsA^a
3. Initiated protocol prohibited medications/therapies for PsA^a
4. Discontinued study intervention injections due to Natural Disaster or Major Disruption^b
5. Severe treatment non-compliance due to study site access restrictions, defined as ≥2 doses of study intervention missed due to Natural Disaster or Major Disruption^b

csDMARD conventional synthetic disease-modifying antirheumatic drug, ICE intercurrent event, Major Disruption disruption in Ukraine and neighboring countries/territories beginning February 24, 2022, Natural Disaster site closure, site access restrictions, or lockdowns caused by COVID-19, PsA psoriatic arthritis
^aPatients meeting criteria for ICEs 1–3 are considered nonresponders for the primary endpoint (composite strategy). These ICEs are considered irrelevant to the major secondary endpoint (treatment policy strategy)
^bICEs 4 and 5 follow the hypothetical strategy (see the “ICE strategy and missing data” section)

ISSN: 1745-6215