An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease - Full Text View

An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI LTS)

This study is currently recruiting participants.

Verified March 2012 by Millennium Pharmaceuticals, Inc.

First Received on November 5, 2008. Last Updated on March 26, 2012 History of Changes

Sponsor:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00790933

Purpose

This multicenter, open-label study will collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

Condition	Intervention	Phase
Ulcerative Colitis Crohn's Disease	Drug: vedolizumab	Phase 3

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Ulcerative Colitis

U.S. FDA Resources

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

Primary Outcome Measures:

To determine adverse events, serious adverse events, results of standard laboratory tests and ECGs, time to major IBD-related events (hospitalizations, surgeries or procedures), and improvements in quality of life. [ Time Frame: A maximum of 7 years or until vedolizumab (MLN0002) becomes available in the U.S., whichever occurs first. ] [ Designated as safety issue: No ]

Estimated Enrollment:	2200
Study Start Date:	May 2009
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 A long-term safety study involving intervention followed by observation.	Drug: vedolizumab Enrolled patients will receive vedolizumab (MLN0002) every 4 weeks, starting at Week 0, for up to a maximum of 7 years. The dosing period will be followed by a 16-week post-treatment observation and safety assessment period.Patients will also receive safety phone calls at 6-month intervals for 2 years following receipt of the last dose. Other Name: MLN0002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

a. Previous treatment in Study C13004, Study C13006, Study C13007, or Study 13011 that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790933

Contacts

Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center

1-877-674-3784

medical@mlnm.com

Locations

United States, Alabama
	Recruiting
Birmingham, Alabama, United States, 35233
United States, North Carolina
	Recruiting
Elkin, North Carolina, United States, 28621
Australia, South Australia
	Recruiting
Adelaide, South Australia, Australia, 5000
Belgium
	Recruiting
Leuven, Belgium, 3000
Canada, Alberta
	Recruiting
Edmonton, Alberta, Canada, T6G2X8
Canada, Saskatchewan
	Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czech Republic
	Recruiting
Praha, Czech Republic, 170 04
Germany
	Recruiting
Halle, ST, Germany, 6097
Hungary
	Recruiting
Szekszard, Hungary, 7100
Israel
	Recruiting
Tel Aviv, Israel, 64239
Korea, Republic of
	Recruiting
Seoul, Korea, Republic of, 130-702
Malaysia
	Recruiting
Kuala Lumpur, Malaysia, 59100

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:	NCT00790933 History of Changes
Other Study ID Numbers:	C13008
Study First Received:	November 5, 2008
Last Updated:	March 26, 2012
Health Authority:	United States: Food and Drug Administration

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 May 23, 2012