Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease - Full Text View

Sponsored by:	Millennium Pharmaceuticals, Inc.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00619489

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

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 ]

Estimated Enrollment:	80
Study Start Date:	December 2007
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.

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.

More Information

Responsible Party:	Millennium Pharmaceuticals ( Medical Monitor )
Study ID Numbers:	C13004
Study First Received:	February 11, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00619489
Health Authority:	Canada: Health Canada; Russia: Pharmacological Committee, Ministry of Health

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Crohn Disease

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009