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Impact of Discontinuing Oral Mesalazine on Clinical Remission Response in Ulcerative Colitis Patients in Maintenance Remission Initiating Vedolizumab Therapy: A Multicenter Prospective Randomized Controlled Clinical Study

Impact of Discontinuing Oral Mesalazine on Clinical Remission Response in Ulcerative Colitis Patients in Maintenance Remission Initiating Vedolizumab Therapy: A Multicenter Prospective Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111500
Enrollment
Unknown
Registered
2025-10-31
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

Control group:Continue using mesalazine at the full dose
Experimental group:Discontinue all mesalazine

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age 18 to 80 years; 2.Patients diagnosed with ulcerative colitis according to guidelines and without comorbidities such as Crohn's disease or unclassified inflammatory bowel disease; 3.Patients with ulcerative colitis requiring vedolizumab treatment; 4.Patients requiring vedolizumab treatment and concurrently receiving adequate mesalamine; 5.Patients with ulcerative colitis who have achieved remission with vedolizumab treatment; 6.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of intestinal surgical resection; 2.Patients with a history of vedolizumab use or vedolizumab non-response; 3.Patients with comorbidities requiring vedolizumab treatment; 4.Patients with severe underlying medical conditions who cannot tolerate vedolizumab treatment; 5.Patients who cannot tolerate mesalazine or vedolizumab treatment.

Design outcomes

Primary

MeasureTime frame
Clinical remission response rate;

Secondary

MeasureTime frame
Endoscopic remission response;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactLu Chao

The First Affiliated Hospital of Zhejiang University School of Medicine

chaolu0213@zju.edu.cn+86 571 87236861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026