Trial · NCT07442045
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
NCT07442045, Recruiting, Sixth Affiliated Hospital, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis. Trials, record NCT07442045. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07442045
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
- NCT number
- NCT07442045
- Status
- Recruiting
- Enrollment
- 150 participants, estimated
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- Upadacitinib, Vedolizumab
- First posted
- 2026-03-02
- Last updated
- 2026-07-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Clincial response rate at the 8th week | 8th-week | Clinical response was defined as a decrease from baseline in the modified Mayo score of at least 2 points and at least 30%, accompanied by either a decrease in the rectal-bleeding subscore of at least 1 point or an absolute rectal-bleeding subscore of 1 or less. |
| Secondary | C-Reactive Protein normalization rate at the 8th week | 8th-week | C-reactive protein normalization was evaluated only among patients with a baseline C-reactive protein concentration greater than 5 mg/L. Normalization was defined as a week-8 serum C-reactive protein concentration of 5 mg/L or less. Patients with a baseline C-reactive protein concentration of 5 mg/L or less were not included in the denominator for this outcome. |
| Secondary | Endoscopic remission rate at the 8th week | 8th-week | Endoscopic remission is defined as Mayo endoscopic score(MES) =0 |
| Other | Adverse Events During the 8-Week Induction Period | Week 0 to Week 8 | Safety outcomes included any adverse event, serious adverse events, and permanent treatment discontinuation due to an adverse event. Infections, herpes zoster, thromboembolic events, cardiovascular events, and clinically relevant laboratory abnormalities were recorded when explicitly documented in the electronic medical records, laboratory systems, or medication-administration records. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07442045
GET https://conductscience.org/api/trials/v1/NCT07442045/registered