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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00790933
First received: November 5, 2008
Last updated: June 21, 2013
Last verified: June 2013

November 5, 2008
June 21, 2013
May 2009
March 2016   (final data collection date for primary outcome measure)
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 ]
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 100 weeks or until vedolizumab (MLN0002) becomes commercially available, whichever occurs first. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00790933 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
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

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

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
  • Ulcerative Colitis
  • Crohn's Disease
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
Experimental: 1
A long-term safety study involving intervention followed by observation.
Intervention: Drug: vedolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2200
August 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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)
  2. 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Malaysia,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   Korea, Republic of
 
NCT00790933
C13008
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP