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Taking people in NetherlandsPhase 4

Tests lower-dose subcutaneous vedolizumab in people with inflammatory bowel disease

Tests whether a lower dose of vedolizumab works for adults with inflammatory bowel disease.

Key facts

Who runs it
Stichting Amsterdam UMC
Where
Amsterdam, Groningen, Leiden, Maastricht, Nijmegen, Rotterdam, and Utrecht, NetherlandsSee the 7 sites
Registry title
SIMBA
Status
Recruiting
Phase
Phase 4
People taking part
278 people, planned
Started
16 Jul 2025
Planned end
31 Aug 2026
Type of study
Interventional
Record updated
28 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Crohn's disease or ulcerative colitis who are in remission without steroids and have used vedolizumab injections under the skin every two weeks for six months or more.

Age
18 to 64 years
Sex
Men and women
Disease stage
Crohn's disease or ulcerative colitis in clinical and biochemical remission without steroids
Earlier treatment
Vedolizumab injected under the skin every two weeks for six months or more

Main reasons for not taking part

  • Use of corticosteroids
  • Active fistula
  • Need for surgery related to inflammatory bowel disease

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Adults diagnosed with Crohn's Disease or Ulcerative Colitis in steroïd-free clinical and biochemical remission treated with bi-weekly subcutaneous vedolizumab for six or more months

Who cannot take part

  • Use of corticosteroïds, active fistula or need for IBD-related surgery

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in Netherlands

  • Amsterdam UMCAmsterdam, NetherlandsTaking people
  • UMC GroningenGroningen, NetherlandsTaking people
  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
  • Maastricht University Medical CenterMaastricht, NetherlandsTaking people
  • Radboud Universitair Medisch Centrum (Radboudumc)Nijmegen, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people

About the trial

What the trial wants to find out

Evaluating the effectiveness of subcutaneous vedolizumab dose de-escalation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Subcutaneous vedolizumab drug de-escalation in inflammatory bowel disease: a multicentre randomised controlled study
Plain-language title
Tests lower-dose subcutaneous vedolizumab in people with inflammatory bowel diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2024-514740-82-00, who can take part
Record updated
28 May 2025