A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease Save

Date Added
February 13th, 2018
PRO Number
Pro00074819
Researcher
Jose Quiros

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Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

This is a long-term extension study enrolling male and female pediatric subjects with ulcerative colitis (UC) or Crohn's disease (CD) who initiated vedolizumab intravenous (IV) treatment in the phase 2 Study MLN0002-2003 between the ages of 2 and 17 years of age. The study will evaluate the long-term safety of vedolizumab administered by IV infusion in pediatric subjects with UC or CD. The study will also evaluate the effect of long-term vedolizumab IV treatment on the time to major IBD-related events (hospitalizations, surgeries, or procedures), health-related quality-of-life measurements, patterns of growth and development, and exploratory efficacy measures. Up to 80 rollover subjects from Study MLN0002-2003 will participate in this study. Subjects who weigh 30 kg or greater will receive vedolizumab 300 mg (high dose) or 150 mg (low dose) Q8W. Subjects who weight less than 30 kg will receive vedolizumab 200 mg (high dose) or 100 mg (low dose) IV. Patients will receive treatment and perform assessments every 8 weeks for up to 5 years or until the subject withdraws from the study or the sponsor decides to close the study, whichever comes first.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

A Phase 2 Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety, and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohns Disease. Save

Date Added
February 13th, 2018
PRO Number
Pro00074924
Researcher
Jose Quiros

Silhouette
Keywords
Bowel, Crohn's Disease, Digestive System, Pediatrics
Summary

The purpose of this research study is to determine which dose is effective and how the body processes the study drug, vedolizumab in children ages 2-17 who have ulcerative colitis or Crohn's disease.

This phase 2 study includes a 4-week Screening Period, a 22-week
Treatment Period (with last dose at Week 14). Subjects who do not
enter the long term extension study will have an 18-week Follow-up Period starting
from their last dose of study drug and a long-term follow-up safety
survey by telephone 6 months after their last dose of study drug.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-0387
hudsoncm@musc.edu

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease Save

Date Added
October 24th, 2017
PRO Number
Pro00070046
Researcher
Nilesh Lodhia
Keywords
Crohn's Disease, Disease Prevention
Summary

This is a 5 year observational study of patients with Inflammatory Bowel Disease (IBD), which includes Crohn's disease, Ulcerative colitis and Indeterminate colitis, to learn more about people who have IBD and the medications that they take. The study includes an optional biospecimen repository to investigate viral resistance, genomics, and biomarkers, and that retrospective data on these IBD patients will be reserved.

Institution
MUSC
Recruitment Contact
Jamila Keith
843-876-7233
keithja@musc.edu

Gene Discoveries in Subjects with Crohn's Disease of African Descent Save

Date Added
September 2nd, 2014
PRO Number
Pro00034427
Researcher
Jose Quiros

Silhouette
Keywords
Bowel, Children's Health, Crohn's Disease, Digestive System, Ethnicity and Disease, Genetics, Minorities, Pediatrics
Summary

A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children's Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.

The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

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