the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Ulcerative Colitis

NCT06856031 | Completed

• 1 other identifier: SAHoWMU-CR2025-01-204
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBD (Inflammatory Bowel Disease)

Keywords

Ulcerative colitis; vedolizumab; drug retention; influencing factors

Outcome Measures

Primary Outcomes (2)

• Drug retention rates analyzed at weeks 54 of vedolizumab treatment

  the drug retention rate of vedolizumab

  at week 54

• Drug retention rates analyzed at weeks 108 of vedolizumab treatment

  the drug retention rate of vedolizumab

  at week 108

Secondary Outcomes (13)

• Analyze the impact of baseline MES on VDZ drug retention rates

  at week 54 and 108

• Analyze the impact of baseline disease sites on VDZ drug retention rates

  at week 54 and 108

• Analyze the impact of baseline modified Mayo score on VDZ drug retention rates

  at week 54 and 108

• Analyze the impact of duration of disease on VDZ drug retention rates

  at week 54 and 108

• Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates

  at week 54 and 108

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• Diagnosed with moderate to severe ulcerative colitis
• Receiving treatment with vedolizumab

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 4, 2025
• Study Start: November 1, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)