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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: 12 May 2014
Main ID:  EUCTR2008-002783-33-IT
Date of registration: 17/03/2009
Prospective Registration: Yes
Primary sponsor: MILLENNIUM PHARMACEUTICALS, INC.
Public title: Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND
Scientific title: Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND
Date of first enrolment: 22/07/2009
Target sample size: 1060
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002783-33
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Austria Belgium Bulgaria Czech Republic Denmark Estonia France Germany
Greece Hungary Iceland Ireland Italy Latvia Malta Netherlands
Portugal Slovakia Spain Sweden United Kingdom
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 post-menopausal 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, at the same time, from four weeks before the first dose of study drug through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (ie, status post-vasectomy), 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 Crohn?s disease established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of Crohn?s disease established at least 12 months prior to enrollment for which a histopathology report is not available will be considered based on the weight of the evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis prior to enrollment. 5. Moderately to severely active Crohn?s disease as determined by a CDAI score of 220 to 480 (see Section 15.1) within 7 days prior to the first dose of study drug 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; aphthous ulcerations are not sufficient) consistent with CD within 4 months prior to 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 left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (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 (may be performed during screening)(See protocol pp. 40-41)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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 prior to study drug administration. 3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, 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 prior to 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) any other type of non-melanoma skin cancer that has been adequately treated and has not recurred for at least 1 year prior to enrollment; and (c) adequately treated in situ cervical cancer that has not recurred for at least 1 year prior to enrollment 6. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease 7. Positive PML subjective symptom checklist prior to the administration of the first dose of study drug 8. Any of the following laboratory abnormalities during the screening period: a. Hemoglobin level <8 g/dL b. WBC count <3 × 109/L c. Lymphocyte count <0.5 × 109/L d. Platelet count <100 × 109/L or >1200 × 109/L e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN) f. Alkaline phosphatase >3 × ULN g. Serum creatinine >2 × ULN 9. Current or recent history (within one year prior to enrollment) of alcohol dependence or illicit drug use 10. Active psychiatric problems that, in the investigator?s opinion, may interfere with compliance with the study procedures 11. Unable to attend all the study visits or comply with study procedures.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with Moderate to Severe Crohn?s Disease
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Intervention(s)

Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for infusion*
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: Powder for infusion*
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: Primary Objective for the Induction Phase To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeks for the Maintenance Phase To determine the effect of MLN0002 maintenance treatment on clinical remission at 52 weeks
Primary end point(s): For the Induction Phase: Proportion of patients with clinical response at Week 6. For the Maintenance Phase: proportion of patients in clinical remission at Week 52.
Secondary Objective: for the Induction Phase To determine the effect of MLN0002 induction treatment on enhanced clinical response at 6 weeks To determine the effect of MLN0002 induction treatment on serum C-reactive protein (CRP) levels at 6 weeks in patients with elevated CRP levels at baseline for the Maintenance Phase To determine the effect of MLN0002 maintenance treatment on enhanced clinical response at 52 weeks To determine the effect of MLN0002 maintenance treatment on corticosteroid-free remission at 52 weeks To determine the effect of MLN0002 maintenance treatment on durability of clinical remission
Secondary Outcome(s)
Secondary ID(s)
2008-002783-33-ES
C13007
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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