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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00790933
Date of registration: 05/11/2008
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease GEMINI LTS
Scientific title: A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease
Date of first enrolment: May 22, 2009
Target sample size: 2243
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00790933
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Belgium Canada Czech Republic Czechia Germany Hungary Israel
Korea, Republic of Malaysia United States
Contacts
Name:     Medical Monitor Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study
C13007 (NCT00783692), or Study C13011 (NCT01224171) 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52]
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76]
Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52]
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76]
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124]
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172]
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28]
Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352]
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52]
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124]
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172]
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52]
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 [Time Frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76]
Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings [Time Frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)]
Number of Participants With Markedly Abnormal Safety Laboratory Findings [Time Frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)]
Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements [Time Frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)]
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)]
Time to Major Inflammatory Bowel Disease (IBD) - Related Events [Time Frame: Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)]
Secondary Outcome(s)
Secondary ID(s)
10/H1102/12
2008-002784-14
C13008
CTRI/2009/091/000138
NL25209.096.08
NMRR-08-1040-2195
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 12/03/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00790933
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