Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
NCT ID: NCT03839680
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
2018-02-01
2019-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life
NCT03378388
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
NCT03535649
Value of Pharmacokinetic Assays in the Prediction of Therapeutic Response in Ulcerative Colitis
NCT03724929
Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
NCT03824561
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
NCT03029143
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopy
The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* established diagnosis of ulcerative colitis for at least 3 months
* moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score ≥ 1 before vedolizumab introduction
* patients receiving vedolizumab according to French drug labelling (previous exposure to anti-TNF, contraindicated or intolerant to anti-TNF),
* possibility of concomitant therapy including corticosteroids and immunosuppressors,
* patients naive to anti-integrin,
* no contraindication to proctosigmoidoscopy
Exclusion Criteria
* ulcerative colitis not proven, Crohn's disease, or inderterminate colitis
* personal history of high-grade dysplasia or colorectal cancer
* surgery with ileo-anal anastomosis
* patients' refusal to participate in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Besançon
Besançon, , France
CHU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
CHI de Haute-Saône
Vesoul, , France
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P/2019/412
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.