Overview

This trial is active, not recruiting.

Conditions ulcerative colitis, crohn's disease
Treatment vedolizumab
Phase phase 3
Sponsor Takeda
Start date May 2009
End date July 2017
Trial size 2243 participants
Trial identifier NCT00790933, 10/H1102/12, 2008-002784-14, C13008, CTRI/2009/091/000138, NMRR-08-1040-2195

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose other
Masking no masking
Arm
(Experimental)
Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for up to 46 months.
vedolizumab MLN0002
Vedolizumab intravenous infusion

Primary Outcomes

Measure
Percentage of Participants with one or more Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From first dose to 16 weeks after the last dose up to data cut off: 21 May 2015
Number of Participants with Markedly Abnormal Safety Laboratory Findings
time frame: From first dose to 16 weeks after the last dose up to data cut-off: 21 May 2015
Percentage of Participants with Markedly Abnormal Vital Sign Measurements
time frame: From first dose to 16 weeks after the last dose up to data cut-off: 21 May 2015
Number of Participants with Markedly Abnormal Safety Electrocardiogram (ECG) Reported as Adverse Events
time frame: From first dose to 16 weeks after the last dose up to data cut-off: 21 May 2015
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
time frame: Baseline up to data cut-off: 21 May 2015
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
time frame: Baseline and Week 28
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
time frame: Baseline and Week 52
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
time frame: Baseline and Week 76
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
time frame: Baseline and Week 100
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
time frame: Baseline and Week 124
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
time frame: Baseline and Week 148
Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
time frame: Baseline and Week 196
Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
time frame: Baseline and Week 28
Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
time frame: Baseline and Week 28
Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
time frame: Baseline and Week 52
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
time frame: Baseline and Week 52
Change from Baseline in Short Form-36 (SF-36) Physical Component at Week 76
time frame: Baseline and Week 76
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
time frame: Baseline and Week 76
Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
time frame: Baseline and Week 100
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
time frame: Baseline and Week 100
Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 124
time frame: Baseline and Week 124
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 124
time frame: Baseline and Week 124
Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
time frame: Baseline and Week 148
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
time frame: Baseline and Week 148
Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
time frame: Baseline and Week 196
Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
time frame: Baseline and Week 196
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 28
time frame: Baseline and Week 28
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 28
time frame: Baseline and Week 28
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 52
time frame: Baseline and Week 52
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 52
time frame: Baseline and Week 52
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 76
time frame: Baseline and Week 76
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 76
time frame: Baseline and Week 76
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 100
time frame: Baseline and Week 100
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 100
time frame: Baseline and Week 100
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 124
time frame: Baseline and Week 124
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 124
time frame: Baseline and Week 124
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 148
time frame: Baseline and Week 148
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 148
time frame: Baseline and Week 148
Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 196
time frame: Baseline and Week 196
Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 196
time frame: Baseline and Week 196

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

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
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 up to 46 months. This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to March 2016 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Takeda.