Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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 or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Vedolizumab

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