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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00790933




Registration number
NCT00790933
Ethics application status
Date submitted
5/11/2008
Date registered
14/11/2008

Titles & IDs
Public title
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
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
Secondary ID [1] 0 0
2008-002784-14
Secondary ID [2] 0 0
C13008
Universal Trial Number (UTN)
Trial acronym
GEMINI LTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab

Experimental: Vedolizumab 300 mg - Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 weeks.


Treatment: Drugs: Vedolizumab
Vedolizumab intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Timepoint [2] 0 0
From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Primary outcome [3] 0 0
Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements
Timepoint [3] 0 0
From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Primary outcome [4] 0 0
Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
Timepoint [4] 0 0
From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Primary outcome [5] 0 0
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Timepoint [5] 0 0
Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)
Primary outcome [6] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
Timepoint [7] 0 0
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
Primary outcome [8] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
Timepoint [8] 0 0
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
Primary outcome [9] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
Timepoint [9] 0 0
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
Primary outcome [10] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
Timepoint [10] 0 0
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
Primary outcome [11] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
Timepoint [11] 0 0
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
Primary outcome [12] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
Timepoint [12] 0 0
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
Primary outcome [13] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
Timepoint [13] 0 0
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
Primary outcome [14] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
Timepoint [14] 0 0
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
Primary outcome [15] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
Timepoint [15] 0 0
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
Primary outcome [16] 0 0
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
Timepoint [16] 0 0
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
Primary outcome [17] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
Timepoint [17] 0 0
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
Primary outcome [18] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
Timepoint [18] 0 0
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
Primary outcome [19] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
Timepoint [19] 0 0
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
Primary outcome [20] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
Timepoint [20] 0 0
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
Primary outcome [21] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
Timepoint [21] 0 0
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
Primary outcome [22] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
Timepoint [22] 0 0
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
Primary outcome [23] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
Timepoint [23] 0 0
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
Primary outcome [24] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
Timepoint [24] 0 0
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
Primary outcome [25] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
Timepoint [25] 0 0
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
Primary outcome [26] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
Timepoint [26] 0 0
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
Primary outcome [27] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
Timepoint [27] 0 0
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
Primary outcome [28] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
Timepoint [28] 0 0
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
Primary outcome [29] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
Timepoint [29] 0 0
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
Primary outcome [30] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
Timepoint [30] 0 0
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
Primary outcome [31] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
Timepoint [31] 0 0
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
Primary outcome [32] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
Timepoint [32] 0 0
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
Primary outcome [33] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
Timepoint [33] 0 0
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
Primary outcome [34] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
Timepoint [34] 0 0
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
Primary outcome [35] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
Timepoint [35] 0 0
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
Primary outcome [36] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
Timepoint [36] 0 0
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
Primary outcome [37] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
Timepoint [37] 0 0
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
Primary outcome [38] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
Timepoint [38] 0 0
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
Primary outcome [39] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
Timepoint [39] 0 0
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
Primary outcome [40] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
Timepoint [40] 0 0
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
Primary outcome [41] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
Timepoint [41] 0 0
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
Primary outcome [42] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
Timepoint [42] 0 0
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
Primary outcome [43] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76
Timepoint [43] 0 0
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
Primary outcome [44] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76
Timepoint [44] 0 0
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
Primary outcome [45] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100
Timepoint [45] 0 0
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
Primary outcome [46] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100
Timepoint [46] 0 0
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
Primary outcome [47] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124
Timepoint [47] 0 0
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
Primary outcome [48] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124
Timepoint [48] 0 0
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
Primary outcome [49] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148
Timepoint [49] 0 0
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
Primary outcome [50] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148
Timepoint [50] 0 0
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
Primary outcome [51] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172
Timepoint [51] 0 0
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
Primary outcome [52] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172
Timepoint [52] 0 0
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
Primary outcome [53] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196
Timepoint [53] 0 0
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
Primary outcome [54] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196
Timepoint [54] 0 0
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
Primary outcome [55] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248
Timepoint [55] 0 0
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
Primary outcome [56] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248
Timepoint [56] 0 0
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
Primary outcome [57] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300
Timepoint [57] 0 0
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
Primary outcome [58] 0 0
Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300
Timepoint [58] 0 0
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
Primary outcome [59] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352
Timepoint [59] 0 0
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
Primary outcome [60] 0 0
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352
Timepoint [60] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Development of any new, unstable, or uncontrolled disease

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/10/2017
Sample size
Target
Accrual to date
Final
2243
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Saskatchewan
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha
Country [24] 0 0
Germany
State/province [24] 0 0
Saint
Country [25] 0 0
Hungary
State/province [25] 0 0
Szekszard
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor Clinical Science
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00790933