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NCT Number: NCT06269185

Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

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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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Västra Götalandsregionen

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Percentage of patients achieving steroid-free clinical remission

    Time frame: One year after start of anti-TNF therapy

    Partial Mayo score ≤2 with no subscore >1 and no use of steroids between 6 and 12 months after start of anti-TNF therapy (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

Secondary outcomes

  1. Percentage of patients achieving clinical response

    Time frame: Three months after start of anti-TNF therapy

    A decrease in the partial Mayo score from baseline of 2 or more points, along with either a rectal bleeding subscore of 0 or 1 or a decrease in the rectal bleeding subscore of 1 point or more (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

  2. Percentage of patients achieving clinical remission

    Time frame: Three months after start of anti-TNF therapy

    Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

  3. Percentage of patients achieving biochemical remission

    Time frame: Three months after start of anti-TNF therapy

    Fecal Calprotectin <250 mg/kg

  4. Percentage of patients achieving clinical remission

    Time frame: One year after start of anti-TNF therapy

    Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

  5. Percentage of patients achieving biochemical remission

    Time frame: One year after start of anti-TNF therapy

    Fecal Calprotectin <250 mg/kg

  6. Percentage of patients achieving endoscopic response

    Time frame: 3-12 months after start of anti-TNF therapy

    A decrease in endoscopic Mayo score of 1 or more points (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).

  7. Percentage of patients achieving endoscopic remission

    Time frame: 3-12 months after start of anti-TNF therapy

    Endoscopic Mayo score 0-1 (Endoscopic Mayoscore, range 0-3, with higher value indicating more severe disease activity).

Other outcomes

  1. Remission rates in the subpopulations of UC-patients with severe, moderate and mild disease respectively

    Time frame: Three months and one year after start of anti-TNF therapy

    Partial Mayo score ≤2 with no subscore >1 (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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