Status:
COMPLETED
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC o...
Detailed Description
This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00619489
Start Date
December 1 2007
End Date
March 1 2010
Last Update
July 18 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
London Health Sciences Centre
London, Ontario, Canada