Ulcerative Colitis
Conditions
Keywords
ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab
Brief summary
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
Interventions
PROCEDUREEndoscopy
The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1 | 54 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 | 14 weeks |
| Endoscopic pattern of mucosal healing | 54 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1 | 14 weeks | — |
| Risk factors of mucosal healing | 14 weeks | Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis: * Demographic data: age, gender, smoking habit * Characteristics of colitis: median duration of disease before starting VDZ, extension of disease according to the Montreal classification and severity at baseline (Mayo score/UCEIS) * Treatments: * Previous therapy used including number of TNF ɑ antagonist and reason for failure * Concomitant drugs: corticosteroids, immunosuppressors * Biologic tests with blood tests (Haemoglobin, CRP, albumin with dosage in patients 'referent laboratory or hospital laboratory priori to each infusion of VDZ) and fecal calprotectin, realized only in hospital laboratory due to repayment terms, from stool samples or aspiration during proctosigmoidoscopy. |
| Histologic remission defined by a Nancy index score at 0 or 1 | 14 weeks | — |
| Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points | 14 weeks | — |
| Clinical response defined by a decrease in the total Mayo score ≥ 3 points and ≥ 30 %, with a decrease in the sub score for rectal bleeding ≥ 1 or an absolute rectal-bleeding sub-score ≤ 1 | 14 weeks | — |
Countries
France
Outcome results
None listed