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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 18 May 2020
Main ID:  JPRN-JapicCTI-163386
Date of registration: 28/09/2016
Prospective Registration: No
Primary sponsor: Takeda Pharmaceutical Company Limited
Public title: Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease
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
Date of first enrolment: 04/1/2016
Target sample size: 644
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-163386
Study type:  INTERVENTIONAL
Study design:  Pivotal, multicenter, multinational, randomized, double-blind, placebo-controlled trial  
Phase:  3
Countries of recruitment
Japan, Refer to "Other"section
Contacts
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Name: Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information   
Address:  https://www.takeda.com/who-we-are/contact-us/
Telephone: +81-6-6204-2111
Email: -
Affiliation: 
Key inclusion & exclusion criteria
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 Crohn's Disease Activity Index (CDAI) score of 220 to 450 and 1 of the following:
- C-reactive protein (CRP) level >2.87 mg/L OR
- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 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-alpha) antagonists.

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 (ie, 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.


Age minimum: 18
Age maximum: 80
Gender: BOTH
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Intervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-label Induction: vedolizumab IV 300 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
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 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
Primary Outcome(s)
efficacy
Percentage of Participants Achieving Clinical Remission at Week 52
Time Frame: Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score =<150 at Week 52.
Secondary Outcome(s)
efficacy
Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Timeframe; Baseline and Week 52
Enhanced clinical response is defined as a decrease from Baseline of >=100 points in the CDAI score at Week 52.
efficacy
Percentage of Participants Achieving Corticosteroid-free Remission
Timeframe; Baseline and Week 52
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.

efficacy
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Timeframe; Baseline and Week 52
Clinical Remission defined as CDAI score <=150, at Week 52.
Secondary ID(s)
2015-000481-58
NCT02611817
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 21/10/2016
Contact:
-
Eiyukai Yasuda Hospital IRB
-
-
Results
Results available: Yes
Date Posted: 28/04/2020
Date Completed: 14/10/2019
URL: https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-163386
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