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
  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:


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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00790933

  Show 41 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Responsible Party: Takeda
ClinicalTrials.gov 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:
Ulcer
Colitis, Ulcerative
Crohn Disease
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Vedolizumab
Gastrointestinal Agents

ClinicalTrials.gov processed this record on January 24, 2017