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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.
Last refreshed on: 19 October 2017
Main ID:  NCT00619489
Date of registration: 11/02/2008
Prospective Registration: No
Primary sponsor: Millennium Pharmaceuticals, Inc.
Public title: Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Scientific title: Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
Date of first enrolment: December 2007
Target sample size: 72
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Name:     Medical Monitor
Affiliation:  Millennium Pharmaceuticals, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)

- Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD

- Partial Mayo score of 2 - 7 for participants with UC

- Patient should be appropriate candidate for biologic therapy per guidelines

- Up-to-date on cancer screening

- No severe systemic disease

- Patients with evidence of abscess

- Agree to comply with study procedures including contraception

Exclusion Criteria:

- Low lymphocyte counts

- History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other
neurological illness

- Active or recent serious infections

- Recent treatment with biologic (i.e., Remicade) or investigational drug

- Impending surgery

- Any participants with vedolizumab human anti-human antibody (HAHA) titers =1:125 or
with a previous immediate hypersensitivity reaction during or shortly after
vedolizumab infusion

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Drug: vedolizumab
Primary Outcome(s)
Number of Participants With Adverse Events (AEs) [Time Frame: From Day 1 to Day 637]
Number of Participants With Clinically Significant Laboratory Findings [Time Frame: through Day 637]
Number of Participants With Human Anti-human Antibodies (HAHA) [Time Frame: Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.]
Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) [Time Frame: through Day 637]
Secondary Outcome(s)
Saturation of Receptors by Vedolizumab Before Dosing on Days 1, 43, 99, 155 and 267 by ACT-1 Assay [Time Frame: Days 43, 99, 155 and 267, predose]
Saturation of Receptors by Vedolizumab Before Dosing Using the MAdCAM-1-Fc Assay [Time Frame: Days 43, 99, 155 and 267, predose]
Serum Concentration of Vedolizumab Before Dosing [Time Frame: Days 43, 99, 155 and 267, predose]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 18/07/2014
Date Completed:
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