Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
ACTIVEDO
1 other identifier
observational
60
1 country
4
Brief Summary
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedFebruary 15, 2019
January 1, 2019
1.2 years
January 15, 2019
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1
54 weeks
Secondary Outcomes (4)
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
14 weeks
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
30 weeks
Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0
54 weeks
Endoscopic pattern of mucosal healing
54 weeks
Other Outcomes (15)
Risk factors of mucosal healing
14 weeks
Risk factors of mucosal healing
30 weeks
Risk factors of mucosal healing
54 weeks
- +12 more other outcomes
Interventions
The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.
Eligibility Criteria
Patients suffering from ulcerative colitis for who an endoscopic examen is performed
You may qualify if:
- age over 18 years,
- 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
You may not qualify if:
- age under 18 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Besançon
Besançon, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
CHI de Haute-Saône
Vesoul, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2019
First Posted
February 15, 2019
Study Start
February 1, 2018
Primary Completion
April 15, 2019
Study Completion
April 15, 2019
Last Updated
February 15, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share