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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: EUCTR
Last refreshed on: 21 August 2017
Main ID:  EUCTR2009-016488-12-BE
Date of registration: 25/11/2010
Prospective Registration: Yes
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease
Scientific title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease
Date of first enrolment: 08/02/2011
Target sample size: 396
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016488-12
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Austria Belgium Czech Republic Germany Hungary Italy Netherlands Slovakia
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Age 18 to 80.
2. Male or female patient who is voluntarily able to give informed consent.
3. Female patients who:
• Are postmenopausal for at least 1 year before the Screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception.
Male patients, even if surgically sterilized, who:
• Agree to practice effective barrier contraception during the entire study
treatment period and through 6 months after the last dose of study drug, OR
•Agree to completely abstain from heterosexual intercourse.
4. Diagnosis of CD established at least 3 months before enrollment by clinical and
endoscopic evidence and corroborated by a histopathology report.
5. Moderately to severely active CD as determined by a CDAI score of 220 to 400 within 7 days before enrollment and 1 of the following:
a. CRP level > 2.87 mg/L during the Screening period, OR
b. 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, within 4 months before enrollment, OR
c. Fecal calprotectin >250 micro g/g stool during the Screening period in
conjunction with computed tomography (CT) enterography, magnetic
resonance (MR) enterography, contrast-enhanced small bowel radiography,
or wireless capsule endoscopy revealing Crohn’s ulcerations (aphthae not
sufficient), within 4 months before screening.
6. CD involvement of the ileum and/or colon, at a minimum.
7. Patients with extensive colitis or pancolitis of >8 years duration or limited colitis
of >12 years duration must have documented evidence that a surveillance
colonoscopy was performed within 12 months before enrollment (may be
performed during screening).
8. Patients with a family history of colorectal cancer, personal history of increased
colorectal cancer risk, age >50 years, or other known risk factor must be up-todate
on colorectal cancer surveillance.
9. Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1of the following agents as defined below:
• Immunomodulators
o Signs and symptoms of persistently active disease despite a history of
at least one 8-week regimen of oral azathioprine (= 1.5 mg/kg) or
6-MP (= 0.75 mg/kg), OR
o Signs and symptoms of persistently active disease despite a history of
at least one 8-week regimen of methotrexate (= 12.5 mg/week), OR
o History of intolerance of at least 1 immunomodulator.
• TNF alpha antagonists
o Signs and symptoms of persistently active disease despite a history of
at least one 4-week induction regimen of 1 of the following agents:
- Infliximab: 5 mg/kg IV, 2 doses at least 2 weeks apart
- Adalimumab: one 80-mg subcutaneous (SC) dose, followed by
one 40-mg dose, at least 2 weeks apart
- Certolizumab pegol: 400 mg SC, 2 doses at least 2 weeks apart,
OR
o Recurrence of symptoms during scheduled maintenance dosing
following prior clinical benefit, OR
o History of intolerance of at least 1 TNF alpha antagonist.
• Corticosteroids
o Signs and symptoms of persistently active disease despite a history
of at least one 4-week induction regimen that included a dose
equivalent to prednisone 30 mg daily orally for 2 weeks or
intravenously for 1 week, OR
o Two failed attempts to taper corticosteroids to below a dose
equivalent to prednisone 10 mg daily orally on 2 separate occasions

Exclusion criteria:
Gastrointestinal Exclusion Criteria
1. Evidence of abdominal abscess during screening
2. Extensive colonic resection or subtotal or total colectomy
3. History of > 3 small bowel resections or diagnosis of short bowel syndrome
4. Have received tube feeding, defined formula diets, or parenteral alimentation
within 21 days before enrollment
5. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
6. Within 30 days before enrollment, have received any of the following for the
treatment of underlying disease:
a. Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those
specifically listed in Section 6.2.1
b. A nonbiologic investigational therapy
c. An approved nonbiologic therapy in an investigational protocol
d. Adalimumab
7. Within 60 days before enrollment, have received any of the following:
a. Infliximab
b. Certolizumab pegol
c. Any other investigational or approved biological agent, other than local
administration for non-IBD conditions
8. Any prior exposure to natalizumab, efalizumab, or rituximab
9. Use of topical (rectal) treatment with 5-ASA or corticosteroid
enemas/suppositories within 2 weeks before enrollment
10. Evidence of or treatment for C. difficile infection or other intestinal pathogen
within 28 days before enrollment
11. Currently require or are anticipated to require major surgical intervention for CD during the study.
12. History or evidence of adenomatous colonic polyps that have not been removed
13. History or evidence of colonic mucosal dysplasia
14. Diagnosis of ulcerative colitis or indeterminate colitis
Infectious Disease Exclusion Criteria
1. Chronic hepatitis B or C infection
2. Active or latent tuberculosis, regardless of treatment history, as evidenced by any
of the following:
a. History of tuberculosis
b. A positive diagnostic TB test defined as:
i. A positive QuantiFERON test or 2 successive indeterminate
QuantiFERON tests within 1 month before enrollment, OR
ii. A tuberculin skin test reaction => 10 mm ( => 5 mm in patients receiving
the equivalent of > 15 mg/day prednisone) within 3 months before
enrollment
c. Chest X-ray within 3 months before enrollment in which active or latent
pulmonary TB cannot be excluded
3. Any identified congenital or acquired immunodeficiency
4. Any live vaccinations within 30 days before enrollment except for the influenza
vaccine
5. Clinically significant extra-intestinal infection within 30 days before screening or during screening
General Exclusion Criteria
1. Previous exposure to MLN0002.
2. Female patients who are lactating or have a positive serum pregnancy test during
the Screening period or a positive urine pregnancy test on Day 1 before
enrollment.
3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI,
genitourinary, hematological, coagulation, immunological, endocrine/metabolic,
or other medical disorder that, in the opinion of the investigator, would confound
the study results or compromise patient safety.
4. Had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.
5. Any history of malignancy, except for the following: (a) adequately treated
nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
adequately treated and that has not recurred for at least 1 year before enrollment;
and (c) history of cervical carcinoma in situ that has been adequately treated and
that has not recurred for a


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Moderate to Severe Crohn's Disease
MedDRA version: 14.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Intervention(s)

Product Name: VEDOLIZUMAB
Product Code: MLN0002
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VEDOLIZUMAB
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumour necrosis factor alpha (TNF alpha) antagonist therapy (TNF alpha subpopulation).
Primary end point(s): • Proportion of patients in clinical remission at Week 6 in the TNF alpha subpopulation
Secondary Objective: To determine the effect of vedolizumab induction treatment on clinical remission at
Week 6 in the entire study population
To determine the effect of vedolizumab induction treatment on clinical remission at
Week 10 in the TNF alpha subpopulation and in the entire study population
To determine the effect of vedolizumab induction treatment on sustained clinical
remission (ie, clinical remission at both Week 6 and Week 10) in the TNF alpha
subpopulation and in the entire study population
To determine the effect of vedolizumab induction treatment on enhanced clinical
response at Week 6 in the TNF alpha subpopulation
Secondary Outcome(s)
Secondary ID(s)
2009-016488-12-NL
C13011
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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