Ulcerative Colitis (UC)
Conditions
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.
Interventions
DRUGUpadacitinib
Oral upadacitinib 45mg/d for 8 weeks in the induction therapy.
DRUGVedolizumab
Vedolizumab 300mg intravenously on weeks 1, 2, 6, and then on every 8-week interval.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis * Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2 * Indications for VDZ or UPA application
Exclusion criteria
* Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy * Evidence of toxic megacolon was found during screening * Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC * Subjects who require surgery due to UC or plan to undergo elective surgery during the study period * There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases * Evidence of active hepatitis B or C infection during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 8th-week endoscopic remission rate | 8th-week | endoscopic subscale (ESS) =0, which defined as endoscopic remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate at the 8th week | 8th-week | Clinical remission is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0. |
| clincial response rate at 8th-week | 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. |
| Endoscopic response rate at 8th-week | 8th-week | Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline |
| normalization rate of CRP at the 8th week | 8th-week | normalization rate of C reactive protein (CRP) |
| 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. |
| Clinical remission rate at the 54th-week | 54th-week | clincial remisson is defined as a total Mayo score ≤2, with no individual subscore \>1 and a rectal bleeding subscore of 0. |
| Clinical response rate at 54th week | 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. |
| endoscopic remission rate at 54th-week | 54th-week | endoscopic subscale (ESS) =0, which defined as endoscopic remission |
| Endoscopic response rate at 54th-week | 54th-week | Endoscopic response is defined as a decrease in the Mayo endoscopic subscore by ≥1 point from baseline |
| normalization rate of CRP at the 54th week | 54th-week | normalization rate of CRP |
| 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. |
Countries
China
Outcome results
None listed