Clinical trial NCT00790933: An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Crohn's Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 2243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

Detailed description: The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.

The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:

• Vedolizumab 300 mg

All participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks.

This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Participants With Markedly Abnormal Safety Laboratory Findings
timeFrame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
measure: Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements
timeFrame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
measure: Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
measure: Time to Major Inflammatory Bowel Disease (IBD) - Related Events
timeFrame: Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
timeFrame: 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
measure: Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
timeFrame: 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
measure: Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300
timeFrame: 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
measure: Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352
timeFrame: 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
measure: Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Lafayette
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Hamden
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Cheektowaga
country: United States
state: New York
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Elkin
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Germantown
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide
country: Australia
state: South Australia
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Saskatoon
country: Canada
state: Saskatchewan
city: Praha
country: Czechia
city: Halle
country: Germany
state: Saint
city: Szekszard
country: Hungary
city: Tel Aviv
country: Israel
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
Study officials:
affiliation: Takeda
name: Medical Monitor Clinical Science
role: STUDY_DIRECTOR
References:
citation: Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
citation: Wyant T, Yang L, Lirio RA, Rosario M. Vedolizumab Immunogenicity With Long-Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease. J Clin Pharmacol. 2021 Sep;61(9):1174-1181. doi: 10.1002/jcph.1877. Epub 2021 Jul 14.
citation: Loftus EV Jr, Feagan BG, Panaccione R, Colombel JF, Sandborn WJ, Sands BE, Danese S, D'Haens G, Rubin DT, Shafran I, Parfionovas A, Rogers R, Lirio RA, Vermeire S. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020 Oct;52(8):1353-1365. doi: 10.1111/apt.16060. Epub 2020 Sep 2.
citation: Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323.
citation: Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7.
citation: Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.