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

Who is this study for? Child to young adult patients with Crohn's Disease
What treatments are being studied? Methotrexate
Status: Completed
Location: See all (32) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 20
Healthy Volunteers: No
View:

• Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating anti-TNF therapy with infliximab or adalimumab (including biosimilars).

• Diagnosis of Crohn's Disease (CD) established confirmed by the treating clinician, and established by standard clinical criteria (radiography, endoscopy, histology).

• Ability to provide parental permission and child assent (where applicable), or adult consent for patients ages 18-20.

Locations
United States
Alabama
Children's of Alabama
Birmingham
California
Stanford Children's Health
Alto
Connecticut
Yale-New Haven Children's Hospital
New Haven
Delaware
Nemours Children's Health System - Wilmington
Wilmington
Florida
Nemours Children's Health System - Jacksonville
Jacksonville
Nicklaus Children's Hospital
Miami
Nemours Children's Health System - Orlando
Orlando
Georgia
Children's Healthcare of Atlanta at Egleston/Emory University
Atlanta
Iowa
University of Iowa Children's Hospital
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
MassGeneral Hospital for Children
Boston
Michigan
University of Michigan | CS Mott Children's Hospital
Ann Arbor
Missouri
Children's Mercy Hospital
Kansas City
Cardinal Glennon Children's Medical Center
Saint Louis
St. Louis Children's Hospital | Washington University
Saint Louis
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Levine Children's Hospital
Charlotte
Nebraska
Children's Hospital and Medical Center Omaha
Omaha
New York
Mount Sinai Kravis Children's Hospital
New York
Upstate Golisano Children's Hospital
Syracuse
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Rainbow Babies & Children's Hospital
Cleveland
Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
Oklahoma
Oklahoma University Medical Center
Oklahoma City
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville
Virginia
Pediatric Specialists of Virginia
Fairfax
Children's Hospital of The King's Daughters
Norfolk
Vermont
The University of Vermont Children's Hospital
Burlington
Wisconsin
Children's Hospital of Wisconsin
Milwaukee
Time Frame
Start Date: October 2016
Completion Date: April 7, 2022
Participants
Target number of participants: 306
Treatments
Experimental: Methotrexate
Methotrexate (10, 12.5, or 15 mg), once weekly. Weight-based dosing. Ondansetron (4 mg), twice weekly, 1 hour prior to methotrexate dose and the morning after methotrexate dose.~Folic Acid (1 mg) daily
Placebo Comparator: Sugar pill (placebo)
Placebo for methotrexate, once weekly. Placebo for ondansetron, twice weekly, 1 hour prior to methotrexate placebo dose and the morning after methotrexate placebo dose.~Folic Acid (1 mg) daily
Sponsors
Collaborators: National Institutes of Health (NIH), ImproveCareNow (ICN), Grifols Diagnostics Solutions, Inc, Children's Hospital Medical Center, Cincinnati, Patient-Centered Outcomes Research Institute, The Leona M. and Harry B. Helmsley Charitable Trust, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov

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