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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).
Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups.
Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission | Other | Group 1 will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. |
|
| Group 2: Corticosteroid-free clinical remission + biomarker remission. | Other | Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Biological | All participants will begin a vedolizumab induction regimen of 300 mg IV at Weeks 0, 2, 6, and 10 followed by vedolizumab 300 mg IV every 8 weeks starting at Week 14. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48 | Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Corticosteroid-free Transmural healing (TMH)+Endoscopic remission+Clinical remission in group 1 and group 2 at week 48 | Transmural healing is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound. Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena van Hest | Contact | 31205630316 | elena.vanhest@alimentiv.com |
| Name | Affiliation | Role |
|---|---|---|
| Vipul Jairath, MD | Alimentiv Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TLC Clinical Research Inc - Los Angeles | Withdrawn | Los Angeles | California | 90048 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41720589 | Derived | Jairath V, Vuyyuru SK, Zou G, Ma C, Neustifter B, Agboton C, Romo Bautista I, Allocca M, An YK, Begun J, Bryant RV, Danese S, Dubinsky M, Feagan BG, Freire M, Novak KL, Panaccione R, Pudipeddi A, Rubin DT, Sands BE, Sparrow MP, Taylor SA, Gecse KB, Wilkens R, Maaser C. Evaluating treatment to a target of transmural healing in patients with moderately to severely active Crohn's disease: rationale, design and protocol for the randomised controlled VECTORS trial. BMJ Open Gastroenterol. 2026 Feb 20;13(1):e002088. doi: 10.1136/bmjgast-2025-002088. |
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De-identified individual participant data underlying the results reported in this article may be made available upon reasonable request, subject to review and approval by the study sponsor, execution of a data use agreement, and in accordance with participant consent and applicable privacy and data protection requirements.
06JAN2026 - 31JAN2029
De-identified individual participant data underlying the results reported in this article may be made available upon reasonable request, subject to review and approval by the study sponsor, execution of a data use agreement, and in accordance with participant consent and applicable privacy and data protection requirements.
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This is an interventional, randomized, parallel-group, multicenter, controlled study. A total of approximately 304 participants with moderately-to-severely active CD from multiple international sites will be enrolled into this study. All qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different treatment target groups: Group 1 will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission. Randomization will be stratified by the following 3 baseline factors each with 2 levels: prior exposure (within the last 5 years of the screening date) to an approved biologic/small molecule for CD (yes or no), disease location (ileal or colonic), and disease duration (≤ 2 years or >2 years, based on date of diagnosis).
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Study participants and investigators will be unblinded to the treatment target group assignment.
Central readers performing the assessment of IUS, endoscopy, and histology assessments will be blinded to treatment target randomization, participant, treatment received, and timepoint which will be used to determine treatment escalation.
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|
| week 48 |
| Percentage of participants with Corticosteroid-free IUS response+Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS). Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. | week 48 |
| Percentage of participants with Corticosteroid-free Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48 | Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. Total SES-CD score is then summed up the item scores (range, 0-56 points). Clinical Remission is defined by Crohn's Disease Activity Index (CDAI) <150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. | week 48 |
| Percentage of participants with Corticosteroid-free endoscopic response+Clinical response in group 1 and group 2 at week 48 | Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, higher scores indicate more severity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. | week 48 |
| Percentage of participants with Corticosteroid-free clinical remission in group 1 and group 2 at Week 14, Week 22 and Week 48. | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. | week 14, week 22 and week 48 |
| Percentage of participants with Corticosteroid-free Clinical Response in group 1 and group 2 at week 14, week 22 and week 48 | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. | week 14, week 22 and week 48 |
| Crohn's Disease Activity Index(CDAI) total score and corresponding change from baseline during follow-up (Week 6, Week 14, Week 22, Week 30, Week 38, Week 48, Week 64, Week 80, Week 96) in group 1 and group 2 | Crohn's Disease Activity Index (CDAI) consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Percentage of participants with Corticosteroid-free endoscopic response in group 1 and group 2 at week 48 | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). | week 48 |
| SES-CD total score and corresponding change from baseline to Week 48 in group 1 and group 2 | The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). | week 48 |
| Percentage of participants with Transmural healing (TMH) in group 1 and group 2 at week 48 | Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound | week 48 |
| Percentage of participants with Intestinal Ultrasound (IUS) response in group 1 and group 2 at Week 48 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS) | week 48 |
| Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at Week 48 in group 1 and group 2. | week 48 |
| Color Doppler signal (CDS) and corresponding change from baseline at Week 48 in group 1 and group 2. | week 48 |
| International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48 in group 1 and group 2 | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters | week 48 |
| Percentage of participants with Transmural healing (TMH) at week 14, week 22, week 30, week 38, and week 48 in group 1 | Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound | week 14, week 22, week 30, week 38, week 48 |
| Percentage of participants with Intestinal Ultrasound (IUS) response at week 14, week 22, week 30, week 38, and week 48 in group 1 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS) | week 14, week 22, week 30, week 38, week 48 |
| Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 |
| Color Doppler signal (CDS) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 |
| International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters | week 14, week 22, week 30, week 38, week 48 |
| Percentage of participants with Histologic remission at week 48 in group 1 and group 2 | Histologic remission is defined by Robarts Histopathology Index (RHI) score ≤3 (per segment) with subscores of 0 for lamina propria neutrophils and 0 for neutrophils in epithelium, as scored by central reader. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity. | week 48 |
| Percentage of participants with Histologic response at week 48 in group 1 and group 2 | Histologic response is defined as ≥7-point reduction from baseline in RHI, as scored by a central reader. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity. | week 48 |
| Percentage of patients with Biomarker remission at week 48, week 64, week 80 and week 96 in group 1 and group 2 | Biomarker remission is defined as Normalization of C-reactive protein (CRP) <5 mg/mL and fecal calprotectin (FCal) <250 μg/g | week 48, week 64, week 80, week 96 |
| Percentage of patients with Biomarker response at week 48, week 64, week 80 and week 96 in group 1 and group 2 | Biomarker response is defined as ≥50% reduction from baseline in either C-reactive protein (CRP) or fecal calprotectin (FCal) | week 48, week 64, week 80, week 96 |
| Percentage of participants with C-reactive protein (CRP) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | C-reactive protein (CRP) response is defined by ≥50% reduction from baseline | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Percentage of participants with fecal calprotectin (FCal) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | Fecal calprotectin (FCal) response is defined by ≥50% reduction from baseline | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Changes in C-reactive protein (CRP) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Changes in fecal calprotectin (FCal) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| 2-item Patient-Reported Outcome (PRO-2) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | The PRO-2 consists of the 2 CDAI component items: daily stool frequency and abdominal pain. Study participants record the number of liquid or very soft stools and rate abdominal pain (range, 0-3) daily in their participant diary for the 7 days prior to a clinic visit, excluding days of bowel preparation and ileocolonoscopy. The stool frequency and abdominal pain scores are calculated as the average scores over the 7-day period. | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Symptoms and Impacts Questionnaire for CD (SIQ-CD) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | SIQ-CD tool consists of a symptom domain, which includes Gastrointestinal (GI), pain and discomfort, nutrition-related, and fatigue-related symptoms; and an impact domain, which includes concepts related to daily activities, nutrition, emotional well-being, and productivity. | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Urgency Numerical Rating Score (NRS) and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2 | The Urgency NRS evaluates the participant's sense of urgency to have a bowel movement over the previous 24 hours and is rated on an 11-point Likert scale, from 0 for "no urgency" to 10 for "worst possible urgency" | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 |
| Inflammatory Bowel Disease Questionnaire (IBDQ) score and corresponding changes from baseline during follow-up (Weeks 30, week 48 and week 96) in group 1 and group 2 | The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224 | week 30, week 48, week 96 |
| Time to CD-related complication from randomization through Week 96 in group 1 and group 2 | CD-related complication will be defined as any of the following: (1) CD-related surgery; (2) CD-related hospitalization; (3) CD medication-related complication; (4) CD procedure-related complication; (5) Rescue therapy for a documented CD-related flare e.g., new initiation of an advanced therapy other than VDZ (approved biologic or small molecule), dose escalation of vedolizumab, or dose intensification beyond the dose used at randomization of a corticosteroid after Week 48 or; (6) Other CD-related complication | from randomization through Week 96 |
| Time to each component of CD-related complication in group 1 and group 2 | from randomization through Week 96 |
| Percentage of participants who switched to an alternate biologic (yes/no) by Week 48 and Week 96 | week 48, week 96 |
| Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs) in group 1 and group 2 | Defined as the number of participants experiencing the event per 100 person-years (PYs) of exposure. | up to week 96 |
| Medical University of South Carolina (MUSC) |
| Not yet recruiting |
| Charleston |
| South Carolina |
| 29425 |
| United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| Concord Repatriation General Hospital | Recruiting | Concord | New South Wales | 2139 | Australia |
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| Mater Misericordiae Ltd | Recruiting | South Brisbane | Queensland | 4101 | Australia |
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| Calvary Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| The Queen Elizabeth Hospital | Recruiting | Woodville | South Australia | 5011 | Australia |
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| Northern Hospital Epping | Recruiting | Epping | Victoria | 3076 | Australia |
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| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
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| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | Australia |
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| Harry Perkins institute of Medical Research - Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
|
| VITAZ - AZ Nikolaas | Recruiting | Sint-Niklaas | Antwerpen | 9100 | Belgium |
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| Imelda Ziekenhuis Bonheiden | Recruiting | Bonheiden | Antwerp | 2820 | Belgium |
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| University Hospital Ghent | Recruiting | Ghent | East Flanders | 9000 | Belgium |
|
| UZ Leuven-University Hospital Gasthuisberg | Recruiting | Leuven | Flemish Brabant | 3000 | Belgium |
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| AZ Delta - Rumbeke Campus | Recruiting | Roeselare | West Flanders | 8800 | Belgium |
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| ULB Hopital Erasme | Recruiting | Brussels | 1070 | Belgium |
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| University of Calgary | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
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| University of Alberta, Dept of Medicine, Division of Gastroenterology | Recruiting | Edmonton | Alberta | T6G 2X8 | Canada |
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| Viable Clinical Research - Bridgewater | Recruiting | Bridgewater | Nova Scotia | B4V 3N2 | Canada |
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| LHSC - University Campus | Recruiting | London | Ontario | N6A 5A5 | Canada |
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| LHSC - Victoria Hospital | Not yet recruiting | London | Ontario | N6A 5W9 | Canada |
|
| Toronto Immune and Digestive Health Institute Inc. (TIDHI) | Recruiting | Toronto | Ontario | Canada |
|
| Vojenska nemocnice Brno | Not yet recruiting | Brno | South Moravian | 615 00 | Czechia |
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| Fakultni Nemocnice Brno | Not yet recruiting | Brno | South Moravian | 625 00 | Czechia |
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| Herlev Hospital | Recruiting | Herlev | Capital Region | 2730 | Denmark |
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| Nordsjaellands Hospital - Hillerod | Recruiting | Hillerød | Capital Region | 3400 | Denmark |
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| Bispebjerg Hospital | Recruiting | Copenhagen NV | Capital | 2400 | Denmark |
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| Hvidovre Hospital | Recruiting | Hvidovre | Capital | 2650 | Denmark |
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| Aarhus Universitetshospital | Recruiting | Aarhus | Central Denmark | 8200 | Denmark |
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| Randers Regional Hospital | Recruiting | Randers | Central Denmark | 83930 | Denmark |
|
| Sjaellands Universitets hospitall Koge | Withdrawn | Køge | Region Sjælland | 4600 | Denmark |
| Svendborg Hospital | Withdrawn | Svendborg | Denmark |
| Hopital Lyon Sud | Recruiting | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
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| APHM | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13015 | France |
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| Groupe Hospitalier Prive Ambroise Pare - Hartmann | Withdrawn | Neuilly-sur-Seine | France |
| Universitatsklinikum Augsburg | Not yet recruiting | Augsburg | Bavaria | 86156 | Germany |
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| Universitatsklinkum Frankfurt - Goethe Universitat | Withdrawn | Frankfurt am Main | Hesse | 60590 | Germany |
| Klinikum Luneburg | Recruiting | Lüneburg | Lower Saxony | 21339 | Germany |
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| Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
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| Universitats Klinikum Freiburg | Withdrawn | Freiburg im Breisgau | Germany |
| Ospedale Casa Sollievo della Sofferenza IRCCS | Recruiting | San Giovanni Rotondo | Foggia | 71013 | Italy |
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| Ospedale Luigi Sacco | Recruiting | Milan | Lombardy | 20157 | Italy |
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| Ospedale San Raffaele S.r.I. | Not yet recruiting | Milan | Milan | 20132 | Italy |
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| Policlinico Universitario Agostino Gemelli | Recruiting | Roma | Rome | 00168 | Italy |
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| Radboud University Nijmegen Medical Centre | Recruiting | Nijmegen | Gelderland | 6525 | Netherlands |
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| Amsterdam UMC - VU Medisch Centrum | Recruiting | Amsterdam | North Holland | 1081HV | Netherlands |
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| Erasmus Medisch Centrum (MC) | Not yet recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| ETZ - St. Elisabeth Hospital | Withdrawn | Tilburg | Netherlands |
| Oddzial Gastroenterologiczny SP ZOZ w Lecznej | Recruiting | Łęczna | Gmina Leczna | 21-010 | Poland |
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| SOLUMED Centrum Medyczne | Recruiting | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
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| GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j. | Recruiting | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
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| Melita Medical Sp Zoo | Recruiting | Wroclaw | Lower Silesian Voivodeship | 53-611 | Poland |
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| Bodyclinic Sp.z.o.o. Sp.K | Recruiting | Warsaw | Masovia | 03-712 | Poland |
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| WIP Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | Masovia | 04-501 | Poland |
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| Centrum Medyczne Medyk | Recruiting | Rzeszów | Podkarpackie Voivodeship | 35-326 | Poland |
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| Vita Longa Sp. z o.o. | Recruiting | Katowice | Silesian | 40-748 | Poland |
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| Sonomed Sp. z o.o. - Centrum Medyczne | Recruiting | Szczecin | West Pomerianian | 71-685 | Poland |
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| Twoja Przychodnia-Centrum Medyczne Opole | Withdrawn | Opole | Poland |
| EuroMediCare (EMC) Instytut Medyczny SA | Recruiting | Wroclaw | 54-144 | Poland |
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| LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria | Not yet recruiting | Lisbon | Portugal |
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| Nottingham University Hospitals NHS Trust - QMC | Recruiting | Nottingham | East Midlands | NG7 2UH | United Kingdom |
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| London North West University Healthcare NHS Trust - Northwick Park Hospital | Withdrawn | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Western General Hospital | Not yet recruiting | Edinburgh | EH4 2XU | United Kingdom |
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| Barts Health NHS Trust - The Royal London Hospital | Recruiting | London | E1 2AJ | United Kingdom |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW1 2BU | United Kingdom |
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| Kings College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
Not provided
Not provided
Not provided