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):
Takeda
ClinicalTrials.gov Identifier:
NCT00790933
First received: November 5, 2008
Last updated: January 13, 2017
Last verified: January 2017

November 5, 2008
January 13, 2017
May 2009
March 2016   (Final data collection date for primary outcome measure)
  • Percentage of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events [ Time Frame: Maximum of 10 years ]
  • Percentage of Participants With Markedly Abnormal Safety Laboratory Findings [ Time Frame: Maximum of 10 years ]
  • Percentage of Participants With Markedly Abnormal Vital Sign Measurements [ Time Frame: Maximum of 10 years ]
  • Percentage of Participants With Markedly Abnormal Safety Electrocardiogram (ECG) [ Time Frame: Maximum of 10 years ]
  • Time to major IBD-related events (hospitalizations, surgeries or procedures) [ Time Frame: Maximum of 10 years ]
  • Change from baseline in the Improvements in Quality of Life [ Time Frame: Maximum of 10 years ]
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. ]
Complete list of historical versions of study NCT00790933 on ClinicalTrials.gov Archive Site
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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 10 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2200
December 2017
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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Israel,   Korea, Republic of,   Malaysia
 
 
NCT00790933
C13008, 2008-002784-14, NMRR-08-1040-2195, CTRI/2009/091/000138, 10/H1102/12
Yes
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Takeda
Takeda
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Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Takeda
January 2017

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