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Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy | Procedure | The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1 | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors of mucosal healing | Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
|
Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from ulcerative colitis for who an endoscopic examen is performed
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | France |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0 |
| 54 weeks |
| Endoscopic pattern of mucosal healing | 54 weeks |
| 14 weeks |
| Risk factors of mucosal healing | Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
| 30 weeks |
| Risk factors of mucosal healing | Risk factors will be assessed by consultation of patients medical record and reported on the spreedsheet for analysis:
| 54 weeks |
| Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points | 14 weeks |
| Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points | 30 weeks |
| Endoscopic response defined by a decrease in Mayo endoscopic sub-score ≥1 or decrease in UCEIS ≥ 2 points | 54 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 |
| 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 | 30 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 | 54 weeks |
| Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1 | 14 weeks |
| Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1 | 30 weeks |
| Clinical remission defined by a total Mayo score ≤ 2 with no sub-score > 1 | 54 weeks |
| Histologic remission defined by a Nancy index score at 0 or 1 | 14 weeks |
| Histologic remission defined by a Nancy index score at 0 or 1 | 30 weeks |
| Histologic remission defined by a Nancy index score at 0 or 1 | 54 weeks |
| CHU de Montpellier | Recruiting | Montpellier | France |
|
| CHU de Nantes | Recruiting | Nantes | France |
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| CHI de Haute-Saône | Recruiting | Vesoul | France |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013514 | Surgical Procedures, Operative |