IBD (Inflammatory Bowel Disease)NCT06856031
the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Ulcerative Colitis
An observational study of IBD (Inflammatory Bowel Disease), run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The drug retention rate of vedolizumab for ulcerative colitis decreases with time. This study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Optimized Treatment (OPT)
- Type of treatment
- Injection or infusion
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).
Who may be able to join
- Diagnosed with moderate to severe ulcerative colitis
- Receiving treatment with vedolizumab
Who cannot join
- Combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy.
- Combination of active tuberculosis, Clostridium difficile infection, cytomegalovirus infection, EBV infection, etc.
- Combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.).
- Combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency.
- Loss of visit or clinical data ≥30% during the follow-up period.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis
The drug retention rate of vedolizumab for ulcerative colitis decreases with time. This study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab.
Read the detailed description
Vedelizumab is a humanized monoclonal antibody that specifically recognizes α4β7 heterodimer, selectively blocks the interaction between mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal blood vessels and α4β7 integrins on the surface of lymphocytes, inhibiting the migration of lymphocytes to the gastrointestinal mucosa and thus exerting anti-inflammatory effects. The regimen of vedolizumab therapy for the treatment of ulcerative colitis is intravenous vedolizumab (300 mg) at weeks 0, 2, and 6 for induction therapy, followed by intravenous vedolizumab (300 mg) every 8 weeks for maintenance therapy. This study analyzed the long-term drug retention rate and its influencing factors in moderately and severely active UC patients treated with VDZ, aiming to provide a more precise and personalized treatment plan for UC patients before initiating VDZ therapy, and to better predict drug efficacy as well as retention rate.
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Optimized Treatment (OPT)
- Keywords
- Ulcerative colitis, vedolizumab, drug retention, influencing factors
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized Treatment (OPT)Drug
After induction therapy with intravenous vedolizumab (300 mg) at weeks 0, 2, and 6, PRO2 was assessed to determine the patient's response and an individualized treatment plan was formulated: vedolizumab was reinfused intravenously (300 mg) every 4 weeks if PRO2 was reduced by <50% from baseline or was still in the moderately-severe active phase of PRO2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug retention rates analyzed at weeks 54 of vedolizumab treatment
the drug retention rate of vedolizumab
Measured: at week 54
Drug retention rates analyzed at weeks 108 of vedolizumab treatment
the drug retention rate of vedolizumab
Measured: at week 108
Secondary outcomes (13)
Analyze the impact of baseline MES on VDZ drug retention rates
Analyze the difference in baseline MES between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
The Mayo endoscopic score (MES) was used to assess the degree of intestinal inflammation, with a score of MES=0 defined as mucosal healing, MES=1 as mild, MES=2 as moderate, and MES=3 as severe.
Measured: at week 54 and 108
Analyze the impact of baseline disease sites on VDZ drug retention rates
Analyze the difference in disease sites between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Disease sites were categorized into proctitis (E1), left hemicolonitis (E2) and extensive colitis (E3) based on the Montreal UC phenotypic classification criteria.
Measured: at week 54 and 108
Analyze the impact of baseline modified Mayo score on VDZ drug retention rates
Analyze the difference in the baseline modified Mayo score between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). The modified Mayo score was employed to assess UC disease activity. A modified Mayo score of ≤5 was defined as mild activity, 6-10 as moderate activity, and ≥11 as severe activity.
Measured: at week 54 and 108
Analyze the impact of duration of disease on VDZ drug retention rates
Analyze the difference in duration of disease (in years) between VDZ-continued group and VDZ-discontinued group.
Measured: at week 54 and 108
Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline C-reactive protein (mg/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates
Analyze the difference in baseline erythrocyte sedimentation rate (mm/h) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline 25(OH) D in peripheral blood (ng/mL) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline serum albumin (g/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline absolute eosinophil count in peripheral blood (×10^8) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline hemoglobin in peripheral blood (g/L) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline white blood cell count in peripheral blood (×10^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates
Analyze the difference in baseline platelet count in peripheral blood (×10^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).
Measured: at week 54 and 108
Analysis of the impact of baseline body mass index on VDZ drug retention rates
Analyze the difference in baseline body mass index between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). Body Mass Index (BMI) is a numerical value derived from an individual's weight and height, calculated by dividing the weight in kilograms by the square of the height in meters (kg/m²). Baseline height (m) and weight (kg) of patients need be collected.
Measured: at week 54 and 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Nov 2020
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856031
- Sponsor's protocol ID
- SAHoWMU-CR2025-01-204
- Status last verified
- Mar 2025
- First submitted
- 10 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06856031
- Acronym / sponsor ID
- SAHoWMU-CR2025-01-204
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Ulcerative colitis, vedolizumab, drug retention, influencing factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The drug retention rate of vedolizumab for ulcerative colitis decreases with time. This study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab.
Detailed description
Vedelizumab is a humanized monoclonal antibody that specifically recognizes α4β7 heterodimer, selectively blocks the interaction between mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal blood vessels and α4β7 integrins on the surface of lymphocytes, inhibiting the migration of lymphocytes to the gastrointestinal mucosa and thus exerting anti-inflammatory effects. The regimen of vedolizumab therapy for the treatment of ulcerative colitis is intravenous vedolizumab (300 mg) at weeks 0, 2, and 6 for induction therapy, followed by intravenous vedolizumab (300 mg) every 8 weeks for maintenance therapy. This study analyzed the long-term drug retention rate and its influencing factors in moderately and severely active UC patients treated with VDZ, aiming to provide a more precise and personalized treatment plan for UC patients before initiating VDZ therapy, and to better predict drug efficacy as well as retention rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).
Key inclusion criteria (2 listed)
- Diagnosed with moderate to severe ulcerative colitis
- Receiving treatment with vedolizumab
Key exclusion criteria (5 listed)
- Combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy.
- Combination of active tuberculosis, Clostridium difficile infection, cytomegalovirus infection, EBV infection, etc.
- Combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.).
- Combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized Treatment (OPT)After induction therapy with intravenous vedolizumab (300 mg) at weeks 0, 2, and 6, PRO2 was assessed to determine the patient's response and an individualized treatment plan was formulated: vedolizumab was reinfused intravenously (300 mg) every 4 weeks if PRO2 was reduced by <50% from baseline or was still in the moderately-severe active phase of PRO2. | Drug | – |
Primary outcome
Drug retention rates analyzed at weeks 54 of vedolizumab treatment
Time frame: at week 54
the drug retention rate of vedolizumab
Drug retention rates analyzed at weeks 108 of vedolizumab treatment
Time frame: at week 108
the drug retention rate of vedolizumab
13 secondary outcomes
Analyze the impact of baseline MES on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline disease sites on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline modified Mayo score on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of duration of disease on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates
Time frame: at week 54 and 108
Analysis of the impact of baseline body mass index on VDZ drug retention rates
Time frame: at week 54 and 108
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease), run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug retention rates analyzed at weeks 54 of vedolizumab treatment (time frame: at week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.