Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Sponsor
Vastra Gotaland Region
Study ID
NCT06269185
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2024
Status verified
Mar 2024
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024

Study Design

Enrollment
271 participants (actual)

Arms

  • Arm: Infliximab
    Bio-naive patients with ulcerative colitis who starts treatment with infliximab
  • Arm: Adalimumab
    Bio-naive patients with ulcerative colitis who starts treatment with adalimumab

Primary Outcome Measure

Percentage of patients achieving steroid-free clinical remission [ Time Frame: One year after start of anti-TNF therapy ]

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