Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Combination treatment group A combination treatment of vedolizumab and upadacitinib for 8 weeks in the induction therapy, then followed by a single treatment of vedolizumab in the maintenance therapy |
Drug: Upadacitinib
Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
Other Names:
Drug: Vedolizumab
Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.
Other Names:
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Placebo Comparator: Single treatment group single treatment of vedolizumab both in the induction and maintenance therapy |
Drug: Vedolizumab
Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 8th-week endoscopic remission rate [8th-week]
endoscopic subscale (ESS) =0, which defined as endoscopic remission
- normalization rate of CRP at the 8th week [8th-week]
normalization rate of C reactive protein (CRP)
- Clinical remission and response rate at the 8th week [8th-week]
Clinical remission and response rate
- life quality score at the 8th week [8th-week]
Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.
Secondary Outcome Measures
- normalization rate of CRP at the 54th week [54th-week]
normalization rate of CRP
- Clinical remission and response rate at the 54th-week [54th-week]
Clinical remission and response rate
- life quality score at the 54th week [54th-week]
Inflammatory bowel disease questionnaire (IBDQ), the total score is 32-224, with higher scores indicating better quality of life for patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
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Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
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Indications for VDZ or UPA application
Exclusion Criteria:
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Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
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Evidence of toxic megacolon was found during screening
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Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
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Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
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There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
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Evidence of active hepatitis B or C infection during screening
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023ZSLYEC-469