Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis - Full Text View

Sponsored by:	Millennium Pharmaceuticals, Inc.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00783718

Purpose

This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:

The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission
The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the maintenance of clinical response and remission

Condition	Intervention	Phase
Ulcerative Colitis	Drug: vedolizumab Other: Placebo	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment
Official Title:	A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

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

Primary Outcome Measures:

Proportion of patients with clinical response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Proportion of patients in clinical remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients in clinical remission [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Proportion of patients in clinical response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	826
Study Start Date:	November 2008
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1 arm for Induction Phase 2 arms for Maintenance Phase	Drug: vedolizumab Vedolizumab (MLN0002) is given at weeks 0, 2, 6 and then at 4-week intervals, or 8-week intervals for up to one year.
2: Placebo Comparator Placebo add-on Comparator 1 arm for Induction Phase 1 arm for Maintenance Phase	Other: Placebo The placebo infusion (IV) will be composed of normal saline. This is given at weeks 0, 2, 6 and then at 4-weekly intervals for up to one year.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

1. Age 18 to 80

2 Diagnosis of moderately to severely active ulcerative colitis

3. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol

4. May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol

Exclusion Criteria:

Evidence of abdominal abscess at the initial screening visit
Extensive colonic resection, subtotal or total colectomy
Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
Chronic hepatitis B or C infection
Active or latent tuberculosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783718

Contacts

Contact: For a listing of recruitment sites in your area contact: Millennium Medical and Drug Information Center

1-866-835-2233

medical@mlnm.com

Locations

United States, Georgia
Atlanta Center for Gastroenterology, P.C.	Recruiting
Decatur, Georgia, United States, 30033
Contact 404-296-1986
United States, North Carolina
Northwest Piedmont Clinical Research, Inc.	Not yet recruiting
Elkin, North Carolina, United States, 28621
Contact 336-835-1225

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

More Information

Responsible Party:	Millennium Pharmaceuticals, Inc. ( Asit Parikh, M.D., Associate Medical Director )
Study ID Numbers:	C13006
Study First Received:	October 31, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00783718
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009