Skip to content

Can oral mesalazine be discontinued in patients with Crohn's disease who are in remission and receiving TNF-a therapy

Impact of Discontinuing Oral Mesalazine on Clinical Remission Response in Crohn's Disease Patients in Maintenance Remission Initiating Anti-TNF-a Therapy: A Multicenter Prospective Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110821
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Crohn's Disease

Interventions

Mesalazine discontinuation group:Mesalazine discontinuation
Continue mesalazine treatment group:Continue mesalazine treatment

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 80 years; 2.Patients diagnosed with Crohn's disease according to guidelines and without comorbidities such as ulcerative colitis or inflammatory bowel disease (IBD) of unclassified origin; 3.Patients with Crohn's disease requiring treatment with an anti-TNF-a agent; 4.Patients requiring treatment with an anti-TNF-a agent and concurrently receiving adequate mesalamine (1.0 g, 4 times a day, orally); 5.Patients with Crohn's disease who have achieved remission with an anti-TNF-a agent;

Exclusion criteria

Exclusion criteria: 1.Patients who have not signed the informed consent form and are unwilling to cooperate with treatment; 2.Patients with a history of intestinal surgical resection; 3.Patients with a history of anti-TNF-a use or non-response to anti-TNF-a agents; 4.Patients with other comorbidities requiring anti-TNF-a treatment; 5.Patients with severe underlying medical conditions who cannot tolerate anti-TNF-a treatment; 6.Patients who cannot tolerate mesalazine or anti-TNF-a treatment; 7.Patients with Crohn's disease-related complications such as intestinal fistulas and intestinal infections who are currently unable to use anti-TNF-a treatment;

Design outcomes

Primary

MeasureTime frame
Clinical remission response rate;

Secondary

MeasureTime frame
Incidence of adverse reactions;Endoscopic remission response;

Countries

China

Contacts

Public ContactLu Chao

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

chaolu0213@zju.edu.cn+86 571 87236861

Outcome results

None listed

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