Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-06

Study Completion Date

2024-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infliximab

Bio-naive patients with ulcerative colitis who starts treatment with infliximab

Infliximab

Intervention Type DRUG

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

Adalimumab

Bio-naive patients with ulcerative colitis who starts treatment with adalimumab

Adalimumab

Intervention Type DRUG

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

Interventions

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Infliximab

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

Intervention Type DRUG

Adalimumab

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

Intervention Type DRUG

Eligibility Criteria

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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 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 intravenous corticosteroids).

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No