Spots Global Cancer Trial Database for Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
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Trial Identification
Brief Title: Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy
Study ID: NCT02772965
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.
Detailed Description: Overall study duration: 6 years Multi-center study: up to 42 centers Number of subjects: 425 Duration of treatment for each subject: up to 156 weeks (3 years) The primary endpoint is percent of patients who experienced treatment failure over time.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's of Alabama, Birmingham, Alabama, United States
Stanford Children's Health, Alto, California, United States
Yale-New Haven Children's Hospital, New Haven, Connecticut, United States
Nemours Children's Health System - Wilmington, Wilmington, Delaware, United States
Nemours Children's Health System - Jacksonville, Jacksonville, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Nemours Children's Health System - Orlando, Orlando, Florida, United States
Children's Healthcare of Atlanta at Egleston/Emory University, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
University of Iowa Children's Hospital, Iowa City, Iowa, United States
MassGeneral Hospital for Children, Boston, Massachusetts, United States
Boston Children's Hospital, Boston, Massachusetts, United States
University of Michigan | CS Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
St. Louis Children's Hospital | Washington University, Saint Louis, Missouri, United States
Children's Hospital and Medical Center Omaha, Omaha, Nebraska, United States
Mount Sinai Kravis Children's Hospital, New York, New York, United States
Upstate Golisano Children's Hospital, Syracuse, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Levine Children's Hospital, Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies & Children's Hospital, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee, United States
The University of Vermont Children's Hospital, Burlington, Vermont, United States
Pediatric Specialists of Virginia, Fairfax, Virginia, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Michael D Kappelman, MD
Affiliation: University of North Carolina, Chapel Hill
Role: STUDY_DIRECTOR
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