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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 February 2018
Main ID:  EUCTR2008-002784-14-IE
Date of registration: 28/10/2008
Prospective Registration: Yes
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: "An Open-label Study 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: 09/01/2009
Target sample size: 2200
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: no
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:
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Australia Austria Belgium Bulgaria Canada Czech Republic Estonia France
Germany Greece Hong Kong Hungary Iceland India Ireland Israel
Italy Korea, Republic of Latvia Malaysia Malta Netherlands New Zealand Norway
Poland Portugal Romania Russian Federation Serbia Singapore Slovakia South Africa
Spain Sweden Switzerland Taiwan Turkey Ukraine United Kingdom United States
Contacts
Name: Drug Information Call Center   
Address:  n/a n/a n/a United States
Telephone: +1 510 740 2412
Email: medical@mlnm.com
Affiliation:  Millennium Pharmaceuticals, Inc.
Name: Drug Information Call Center   
Address:  n/a n/a n/a United States
Telephone: +1 510 740 2412
Email: medical@mlnm.com
Affiliation:  Millennium Pharmaceuticals, Inc.
Key inclusion & exclusion criteria
Inclusion criteria:
Previous treatment in prior MLN0002 study that, in the opinion of the
Investigator, was well tolerated
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 1812
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 388

Exclusion criteria:
1. Female patients who are lactating or pregnant.
2. Had any surgical procedure requiring general anesthesia within 30 days prior to
enrollment or is planning to undergo major surgery during the study period
3. Any live vaccinations within 30 days prior to MLN0002 administration except for
the influenza vaccine.
4. Any new, unstable or uncontrolled major medical conditions that would confound 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
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis and Crohn’s Disease
MedDRA version: 14.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
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-

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



Timepoint(s) of evaluation of this end point: Evaluated up to a maximum of 352 weeks or until vedolizumab (MLN0002) becomes available in the applicable country, whichever occurs first
Secondary Outcome(s)
Secondary end point(s): n/a
Timepoint(s) of evaluation of this end point: n/a
Secondary ID(s)
2008-002784-14-EE
C13008
NCT00790933
Source(s) of Monetary Support
Millennium Pharmaceuticals, Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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