BENITIONSClinical Trial Intelligence

Loss of RESponse to Ustekinumab Treated by Dose Escalation

3期 已完成 NCT04245215

适应症Crohn Disease
分期3期
申办方Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
状态已完成
受试者人数108 人
干预(药物)Ustekinumab
开始日期2020年3月11日
完成日期2024年9月25日
结果公布日2026年4月13日

摘要

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time

Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48

week 48 · Participants

Ustekinumab q4w8 Participants
Ustekinumab q8w10 Participants
p-value0.5
Risk Difference (RD)0.0502 (95% CI -0.09487–0.1953)

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。