Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Last updated: October 25, 2024
Sponsor: Vastra Gotaland Region
Overall Status: Completed

Phase

N/A

Condition

Crohn's Disease

Ulcers

Inflammatory Bowel Disease

Treatment

Infliximab

Adalimumab

Clinical Study ID

NCT06269185
2024_IFXvsADAinUC
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-100 years.

  • Diagnosis of ulcerative colitis confirmed by endoscopy and histology.

  • Mild, moderate and severe disease activity.

  • Initiation of IFX or ADA-treatment at one of the centers of the study.

Exclusion

Exclusion Criteria:

  • Clinical remission.

  • Previous colonic surgery (resection of colonic segment or colectomy).

  • Primary indication for anti-TNF therapy by other disease than UC.

  • Prior use of any anti-TNF or other biologic or small molecule therapy.

  • Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenouscorticosteroids).

Study Design

Total Participants: 271
Treatment Group(s): 2
Primary Treatment: Infliximab
Phase:
Study Start date:
March 06, 2024
Estimated Completion Date:
October 18, 2024

Connect with a study center

  • Västra Götalandsregionen

    Göteborg,
    Sweden

    Site Not Available

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