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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: 18 September 2012
Main ID:  EUCTR2008-002784-14-MT
Date of registration: 25/11/2008
Prospective Registration: Yes
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease
Scientific title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease
Date of first enrolment: 28/01/2009
Target sample size: 1508
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002784-14
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Austria Belgium Bulgaria Czech Republic 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. Voluntarily able to give informed consent.

2. Previous treatment in Study C13004, Study C13006 or Study C13007 that, in the opinion of the investigator, was well tolerated. Patients who withdrew early from C13006 or C13007 must have withdrawn due to one of the following:

• Sustained Nonresponse for patients with UC in C13006: Failure to achieve a clinical response (2 point and 25% improvement in partial Mayo score) by Week 14 and a minimum partial Mayo score of =5 points

• Sustained Nonresponse for patients with CD in C13007: Failure to achieve a clinical response (70 point improvement in CDAI score) by Week 14 and a minimum CDAI score of 220 points

• Disease Worsening for patients with UC in C13006: An increase in partial Mayo score of =3 points on 2 consecutive visits from the Week 6 value (or an increase to 9 points on 2 consecutive visits if the Week 6 value >6) and a minimum partial Mayo score of =5 points

• Disease Worsening for patients with CD in C13007: A =100 point increase in CDAI score on 2 consecutive visits from the Week 6 value at any study visit and a minimum CDAI score of 220 points

• Rescue medications for patients in C13006 and C13007: Any new medication or any increase in dose of a baseline medication required to treat new or unresolved UC or CD symptoms (other than antidiarrheals for control of chronic diarrhea)

3. The first dose of MLN0002 in this study (ie, Week 0) must occur not more than 5 weeks after the last dose of study drug in the previous MLN0002 study.

4. Female patients must:
• be post-menopausal for at least 1 year before the screening visit, OR
• be surgically sterile, OR
• (if they are of childbearing potential) agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 6 months after the last dose of study drug, OR
• agree to completely abstain from heterosexual contact.
Male patients, even if surgically sterilized (ie, status post-vasectomy), must:
• 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 contact


5. 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 enrollment

6. 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-to-date on colorectal cancer surveillance.

7. May be receiving a therapeutic dose of the following drugs:

a. Oral 5-ASA compounds
b. Oral corticosteroid therapy (prednisone at a stable dose =30 mg/day, budesonide at a stable dose =9 mg/day, or equivalent steroid)
c. Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories
d. Probiotics (eg, Culturelle, Saccharomyces boulardii)
e. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea
f. Antibiotics used for the treatment of CD (ie, ciprofloxacin, metronidazole).
g. Azathioprine or 6-mercaptopurine, provided the patient was receiving this medication during prior participation in Study C13006 or Study C13007
h. Methotrexate, provided the patient was receiving this medication during prior participation in Study C13007

Are the trial subjects under 18? no
Numbe

Exclusion criteria:
1. Female patients who are lactating or pregnant

2. Required surgical intervention for IBD during or after participation in a prior MLN0002 study, currently require surgical intervention for IBD, or are anticipated to require surgical intervention for IBD during this study

3. Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine

4. Development of any new, unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder during or after participation in a prior MLN0002 study that, in the opinion of the investigator, would confound the study results or compromise patient safety

5. Withdrawal from a previous MLN0002 study due to a study-drug related AE

6. Active psychiatric or substance abuse problems that, in the investigator’s opinion, may interfere with compliance with the study procedures

7. 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
Ulcerative Colitis and Crohn’s Disease
MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis
MedDRA version: 9.1 Level: LLT Classification code 10013099 Term: Disease Crohns
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: 300mg-

Primary Outcome(s)
Main Objective: Primary Objective

• To determine the safety profile of long-term MLN0002 treatment



Primary end point(s): Primary Endpoints

• SAEs, AEs, vital signs, standard laboratory tests (clinical chemistry, hematology, coagulation, urinalysis, and HAHA), and electrocardiograms (ECGs)



Secondary Objective: Resource Utilization and Patient Reported Outcome Objectives

• To determine the effect of long-term MLN0002 treatment on time to major IBD-related events (hospitalizations, surgeries, and IBD-related procedures)

• To determine the effect of long-term MLN0002 treatment on health-related quality of life (QOL) measurements


Exploratory Objective

• To obtain data regarding the effect of long-term MLN0002 treatment on maintaining clinical response and remission



Secondary Outcome(s)
Secondary ID(s)
2008-002784-14-EE
C13008
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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