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 March 2016
Trial size 2200 participants
Trial identifier NCT00790933, 10/H1102/12, 2008-002784-14, C13008, CTRI/2009/091/000138, NMRR-08-1040-2195

Summary

This multicenter, open-label study will 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
Masking open label
Arm
(Experimental)
A long-term safety study involving intervention followed by observation.
vedolizumab MLN0002
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.

Primary Outcomes

Measure
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

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Takeda.