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.
Information provided by (Responsible Party):
Takeda Identifier:
First received: November 5, 2008
Last updated: January 13, 2017
Last verified: January 2017
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:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2200
Study Start Date: May 2009
Estimated Study Completion Date: December 2017
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 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00790933

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
San Diego, California, United States, 92114
San Francisco, California, United States, 94115
United States, Colorado
Lafayette, Colorado, United States, 80026
Littleton, Colorado, United States, 80120
Thorton, Colorado, United States, 80229
United States, Connecticut
Hamden, Connecticut, United States, 06518
United States, Florida
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33172
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta, Georgia, United States, 30024
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
United States, Kansas
Topeka, Kansas, United States, 66606
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Troy, Michigan, United States, 48098
United States, Minnesota
Rochester, Minnesota, United States, 55904
United States, New York
Cheektowaga, New York, United States, 10029
New York, New York, United States, 10029
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Elkin, North Carolina, United States, 28621
United States, Oregon
Portland, Oregon, United States, 97225
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Texas
San Antonio, Texas, United States, 78229
Tyler, Texas, United States, 75701
United States, Virginia
Charlottesville, Virginia, United States, 22908
Richmond, Virginia, United States, 23249
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Leuven, Belgium, 3000
Canada, Alberta
Edmonton, Alberta, Canada, T6G2X8
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czech Republic
Praha, Czech Republic, 170 04
Halle, ST, Germany, 6097
Szekszard, Hungary, 7100
Tel Aviv, Israel, 64239
Korea, Republic of
Seoul, Korea, Republic of, 130-702
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Takeda Identifier: NCT00790933     History of Changes
Other Study ID Numbers: C13008  2008-002784-14  NMRR-08-1040-2195  CTRI/2009/091/000138  10/H1102/12 
Study First Received: November 5, 2008
Last Updated: January 13, 2017

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents processed this record on January 19, 2017