O Efeito de Guselkumabe na Inibição Radiográfica em Pacientes com Artrite Psoriásica Ativa: protocolo do estudo APEX, um ensaio de fase 3b, multicêntrico, randomizado, duplo-cego, controlado com placebo
Trials. 2023 doi: 10.1186/s13063-022-06945-y
Guselkumab was approved for treating the signs and symptoms of active PsA following two Phase 3 global studies, DISCOVER-1 and DISCOVER-2. The Phase 3b APEX study has been designed to address the limitations of DISCOVER-2 and further assess the effects of guselkumab Q4W and Q8W on PsA outcomes.
These outcomes includes clinical efficacy, radiographic progression, and HRQoL, in a biologic-naïve patient population which has been enriched for those more likely to demonstrate radiographic progression.
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