NCT06269185

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 271 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations. The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.

Conditions

• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Infliximab	Infliximab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis
DRUG	Adalimumab	Adalimumab is an antiinflammatory drug (anti-TNF therapy) commonly used in treatment of ulcerative colitis

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2024-02-21
• Last updated: 2024-10-28

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated drug study