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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITING8th-week endoscopic remission rate
endoscopic subscale (ESS) =0, which defined as endoscopic remission
Time frame: 8th-week
Clinical remission rate at the 8th week
Clinical remission is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0.
Time frame: 8th-week
clincial response rate at 8th-week
Clinical response is defined as a decrease in total Mayo score by ≥3 points and ≥30% from baseline, with a decrease in rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
Time frame: 8th-week
Endoscopic response rate at 8th-week
Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline
Time frame: 8th-week
normalization rate of CRP at the 8th week
normalization rate of C reactive protein (CRP)
Time frame: 8th-week
life quality score at the 8th week
Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.
Time frame: 8th-week
Clinical remission rate at the 54th-week
clincial remisson is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0.
Time frame: 54th-week
Clinical response rate at 54th week
Clinical response is defined as a decrease in total Mayo score by ≥3 points and ≥30% from baseline, with a decrease in rectal bleeding subscore by ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
Time frame: 54th week
endoscopic remission rate at 54th-week
endoscopic subscale (ESS) =0, which defined as endoscopic remission
Time frame: 54th-week
Endoscopic response rate at 54th-week
Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline
Time frame: 54th-week
normalization rate of CRP at the 54th week
normalization rate of CRP
Time frame: 54th-week
life quality score at the 54th week
Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.
Time frame: 54th-week
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