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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00619489
First received: February 11, 2008
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

This is an open-label study to determine the long term safety of MLN0002 in patients with Crohn's disease and ulcerative colitis. Approximately 80 patients at centers in North America and Europe will participate in this study. The treatment and observation period is expected to last approximately 21 months.


Condition Intervention Phase
Ulcerative Colitis
Crohn's Disease
Drug: vedolizumab (MLN0002)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Vital signs, standard laboratory tests, physical examinations, and signs and symptoms of progressive multifocal leukoencephalopathy (PML) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assessment for human anti-human antibodies (HAHA) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK assessments will include but are not limited to MLN0002 trough concentration on a limited number of study visits. [ Time Frame: pre-dose day 1, days 43, 99, 155, 267 ] [ Designated as safety issue: No ]
  • PD evaluation on a limited number of study visits will include measurement of the saturation of receptors by MLN0002. [ Time Frame: pre-dose day 1, days 43, 99, 155, 267 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2007
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with no previous exposure to MLN0002 will receive the drug at a dose of 6 mg/kg
Drug: vedolizumab (MLN0002)
Patients with no prior exposure to MLN0002 will receive 6 mg/kg of MLN0002 administered intravenously on Days 1, 15 and 43. After that patients will receive 6 mg/kg every 8 weeks for up to 78 weeks, followed by 90 day observation period for post-treatment assessments of safety.
Other Name: MLN0002
Experimental: 2
Patients rolling over from a previous MLN0002 study will receive MLN0002 a dose of 2 mg/kg
Drug: vedolizumab (MLN0002)
Patients rolling over from a previous MLN0002 study will follow the same dosing and follow-up schedule as Arm 1, however they will receive of a dose of 2 mg/kg.
Other Name: MLN0002

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed and active UC or CD

    • CDAI Score of 220 - 450
    • Partial Mayo 2 - 7
  • Subject should be appropriate candidate for biologic therapy per guidelines
  • Up-to-date on cancer screening
  • No severe systemic disease
  • Agree to comply with study procedures including contraception

Exclusion Criteria:

  • Low lymphocyte counts
  • History of imaging abnormalities, MS, brain tumor or other neurological illness
  • Active or recent serious infections
  • Recent treatment with biologic (ie Remicade) or investigational drug
  • Impending surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619489

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00619489     History of Changes
Other Study ID Numbers: C13004
Study First Received: February 11, 2008
Last Updated: March 19, 2013
Health Authority: Canada: Health Canada
Russia: Pharmacological Committee, Ministry of Health

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014