Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis - Trial NCT06095596

Timeline & Enrollment

Primary Outcome

8th-week endoscopic remission rate,normalization rate of CRP at the 8th week,Clinical remission and response rate at the 8th week,life quality score at the 8th week

Summary

It's of great importance to effectively induce and maintain disease remission in patients
 with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high
 safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the
 experience in clinical practice, the effect onset speed of vedolizumab is relatively slow.
 Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ
 induction. However, the safety of UPA used in situations such as infection and tumors is
 inferior to that of VDZ, and long-term use requires testing for the risk of adverse events
 such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy
 safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ
 and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy,
 can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical
 research data at home and abroad, we plan to conduct a multicenter prospective randomized
 controlled clinical study to provide the evidence-based basis for the efficacy analysis of
 the sequential treatment of moderate to severe UC patients with VDZ and UPA.

ICD-10 Classifications