A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1) - KEEPsAKE 1

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 880 人开始时间: 2019年4月11日最近更新: 2024年3月12日

试验速览

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•Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
•Subject has active disease at Baseline
•Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.
•Presence of either at Screening:
•1. = 1 erosion on radiograph as determined by central imaging review or;
•2. hs-CRP = 3.0 mg/L.
•Subject must have demonstrated an inadequate response (lack of efficacy after minimum 12 week duration of therapy) to previous or current treatment with at least 1 csDMARD at maximally tolerated dose.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 712
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 168

•Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
•Subject has a known hypersensitivity to Risankizumab.
•Subject has previous treatment with biologic agent.

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