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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02611817
Registration number
NCT02611817
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015
Date last updated
25/05/2022
Titles & IDs
Public title
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
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Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
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Secondary ID [1]
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U1111-1168-0845
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Secondary ID [2]
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MLN0002SC-3031
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab SC 108 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Vedolizumab IV 300 mg
Experimental: Vedolizumab SC 108 mg Maintenance Arm - Open-label Induction: vedolizumab IV 300 milligram (mg), infusion at Week 0 (Day 1) and Week 2 (Day 15)
Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Placebo Comparator: Placebo SC Maintenance Arm - Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15)
Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Treatment: Drugs: Vedolizumab SC 108 mg
Vedolizumab SC Injection.
Treatment: Drugs: Placebo
Vedolizumab placebo-matching SC injection.
Treatment: Drugs: Vedolizumab IV 300 mg
Vedolizumab IV Injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission at Week 52
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Assessment method [1]
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Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Enhanced Clinical Response at Week 52
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Assessment method [1]
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Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
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Assessment method [2]
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Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
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Assessment method [3]
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Clinical remission is defined as CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
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Timepoint [3]
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Week 52
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Eligibility
Key inclusion criteria
1. Diagnosis of CD established at least 3 months prior to screening by clinical and
endoscopic evidence corroborated by a histopathology report.
2. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of
the following:
- C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L)
OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations
(involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
- Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening
period in conjunction with computed tomography enterography (CTE), magnetic
resonance enterography (MRE), contrast-enhanced small bowel radiography, or
wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
3. CD involvement of the ileum and/or colon, at a minimum.
4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
immunomodulators, or Tumor necrosis factor-alpha (TNF-a) antagonists.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Evidence of abdominal abscess at Screening.
2. Extensive colonic resection, subtotal or total colectomy.
3. History of >3 small bowel resections or diagnosis of short bowel syndrome.
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
5. Prior exposure to investigational or approved non-biologic therapies (example,
cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying
disease within 30 days or 5 half-lives of screening (whichever is longer).
6. Prior exposure to any investigational or approved biologic or biosimilar agent within
60 days or 5 half-lives of screening (whichever is longer).
7. Prior exposure to vedolizumab.
8. Surgical intervention for CD required at any time during the study.
9. History or evidence of adenomatous colonic polyps that have not been removed, or of
colonic mucosal dysplasia.
10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
microscopic colitis.
11. Active infections.
12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or
latent), or congenital or acquired immunodeficiency. HBV immune participants (that is,
being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive)
may, however, be included.
13. History of any major neurological disorders, including stroke, multiple sclerosis,
brain tumor, or neurodegenerative disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/08/2019
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Sample size
Target
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Accrual to date
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Final
644
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Nepean Hospital - Kingswood
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Royal Adelaide Hospital - Adelaide
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Tennyson Centre Day Hospital - Bedford Park
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Ballarat Base Hospital - Ballarat
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Royal Melbourne Hospital - Melbourne
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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St John of God Subiaco Hospital - Subiaco
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2139 - Concord
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2747 - Kingswood
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5000 - Adelaide
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5042 - Bedford Park
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3350 - Ballarat
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3000 - Melbourne
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3181 - Melbourne
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6150 - Murdoch
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Recruitment postcode(s) [9]
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6008 - Subiaco
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Recruitment outside Australia
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Yaroslavl
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Country [108]
0
0
Serbia
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State/province [108]
0
0
Belgrade
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Country [109]
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0
Serbia
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State/province [109]
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0
Kragujevac
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Country [110]
0
0
Serbia
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State/province [110]
0
0
Novi Sad
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Country [111]
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0
Slovakia
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State/province [111]
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0
Banska Bystrica
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Country [112]
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0
Slovakia
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State/province [112]
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0
Bratislava
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Country [113]
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0
South Africa
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State/province [113]
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Gauteng
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Country [114]
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0
South Africa
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State/province [114]
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0
Western Cape
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Country [115]
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0
Sweden
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State/province [115]
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0
Stockholm
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Country [116]
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0
Taiwan
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State/province [116]
0
0
Taipei
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Country [117]
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0
Turkey
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State/province [117]
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0
Ankara
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Country [118]
0
0
Turkey
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State/province [118]
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0
Istanbul
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Country [119]
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0
Turkey
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State/province [119]
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0
Kocaeli
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Country [120]
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Turkey
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State/province [120]
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Mersin
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Country [121]
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Ukraine
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State/province [121]
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Chernivtsi
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Country [122]
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Ukraine
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State/province [122]
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Dnipro
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Country [123]
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Ukraine
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State/province [123]
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Kharkiv
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Country [124]
0
0
Ukraine
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State/province [124]
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Kherson
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Country [125]
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Ukraine
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State/province [125]
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Kyiv
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Country [126]
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Ukraine
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State/province [126]
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Lviv
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Country [127]
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Ukraine
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State/province [127]
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Odesa
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Country [128]
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0
Ukraine
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State/province [128]
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0
Ternopil
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Country [129]
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0
Ukraine
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State/province [129]
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Vinnytsia
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Country [130]
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Ukraine
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State/province [130]
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Zaporizhzhia
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Country [131]
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United Kingdom
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State/province [131]
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Devon
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Country [132]
0
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United Kingdom
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State/province [132]
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0
Greater London
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Country [133]
0
0
United Kingdom
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State/province [133]
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0
Shropshire
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Country [134]
0
0
United Kingdom
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State/province [134]
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0
West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Takeda
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab
SC) as maintenance treatment in participants with moderately to severely active CD who
achieved clinical response following administration of vedolizumab intravenous (vedolizumab
IV) induction therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02611817
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director Clinical Science
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Address
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Takeda
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0
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Phone
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0
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02611817
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