BridgeMD
MOVE-IT
EU CTIS ID: 2024-517123-39-00
What this study is testing
To investigate if dosage of Vedolizumab (VDZ) and Ustekinumab (UST) based on Therapeutic Drug Monitoring (TDM) is equally as efficient in keeping Inflammatory Bowel Diseases (IBD) in remission as management based on what the treating physician deems best.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ulcerative colitis or Crohn’s disease. Diagnosed, according to universally acknowledged criteria, a minimum of 3 months prior to inclusion
- Age ≥ 18
- Stable treatment with VDZ or UST for at least 3 months prior to inclusion
- Stable disease activity with no change in medical therapy within 3 months prior to inclusion. Mild disease activity, defined defined by fecal calprotectin ≤ 200, and a weighted PRO2 < 14 for CD or a PRO2 ≤3 for UC is allowed.
- No change in medical therapy within 3 months prior to inclusion, as concomitant therapy with other immune suppressants is allowed (Azathioprine, 6-mercaptopurine, Methotrexate, 5-aminosaliclyic acid)
- The patient must be able to understand patient information material
You likely can't join if
- Having a diagnose of indeterminate colitis
- Patients who are pregnant or nursing at time of inclusion
- Having a stoma or pouch
- Fistulizing disease being the primary reason for treatment with VDZ or UST
- Expected eminent change of therapy
- Expected need for surgical intervention within the coming 3 months
See the full eligibility criteria
- Ulcerative colitis or Crohn’s disease. Diagnosed, according to universally acknowledged criteria, a minimum of 3 months prior to inclusion
- Age ≥ 18
- Stable treatment with VDZ or UST for at least 3 months prior to inclusion
- Stable disease activity with no change in medical therapy within 3 months prior to inclusion. Mild disease activity, defined defined by fecal calprotectin ≤ 200, and a weighted PRO2 < 14 for CD or a PRO2 ≤3 for UC is allowed.
- No change in medical therapy within 3 months prior to inclusion, as concomitant therapy with other immune suppressants is allowed (Azathioprine, 6-mercaptopurine, Methotrexate, 5-aminosaliclyic acid)
- The patient must be able to understand patient information material
- The patient must be able to give informed written consent
- Having a diagnose of indeterminate colitis
- Patients who are pregnant or nursing at time of inclusion
- Having a stoma or pouch
- Fistulizing disease being the primary reason for treatment with VDZ or UST
- Expected eminent change of therapy
- Expected need for surgical intervention within the coming 3 months
- Contraindication against continuing treatment with VDZ or UST, including prior acute or delayed infusion reaction to VDZ or UST
- Any active infection requiring parenteral treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus.
- Any condition which the responsible physician finds incompatible with participation in the study
- Patients unable to participate in the collection of symptoms scores
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.