NCT06269185Completed
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 271 (actual)
- First submitted
- 9 Feb 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Ulcerative colitis
- NCT number
- NCT06269185
What you commit to
- Study type: Observational
- Participants enrolled: 271
- From 6 Mar 2024 to the primary completion date, 18 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous colonic surgery (resection of colonic segment or colectomy).
- 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).
Other illness
- Primary indication for anti-TNF therapy by other disease than UC.
Other
- Clinical remission.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Västra Götalandsregionen Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.