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Vedolizumab for Immune Mediated Colitis

NCT04797325 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-08-17

No results posted yet for this study

Summary

This is an open label randomized trial to evaluate the efficacy and treatment duration with vedolizumab to patients with immune mediated colitis. The trial will include 82 patients randomized into two arms, either standard treatment with prednisolone (plus infliximab in severe cases) or vedolizumab treatment up front.

Conditions

  • Immune-Mediated Colitis

Interventions

DRUG

Vedolizumab

Repeatedly vedolizumab infusion at week 0, 2, 6, 14, 22

DRUG

Prednisolone

tablet prednisolone plus infliximab in severe cases.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jakob B Seidelin, professor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797325 on ClinicalTrials.gov