活動性乾癬性関節炎患者の画像的進行抑制に対するguselkumabの効果: フェーズ3a 多施設共同無作為化二重盲検プラセボ対照試験、APEX試験のプロトコル
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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