306
Participants
Start Date
October 31, 2016
Primary Completion Date
April 7, 2022
Study Completion Date
April 7, 2022
Methotrexate
"1. Oral methotrexate (MTX): The weekly dose will be 15 mg for children ≥ 40kg, 12.5 mg for children 30 to \<40 kg, and 10 mg for children 20 to \<30 kg.~2. A twice per week, 4mg dose of ondansetron will be provided as pre-treatment to prevent nausea (study provider may opt-out of this component based on clinical judgement).~3. A 1 mg dose of folic acid per day will be provided. This will help to reduce the risk of side effects in the MTX group.~Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits."
Sugar pill (placebo)
"1. Placebo for methotrexate: The weekly dose will mimic that of methotrexate.~2. Placebo for ondansetron: The weekly dose will mimic that of ondansetron (study provider may opt-out of this component based on clinical judgement).~3. A 1 mg dose of folic acid per day will be provided to maintain blinding.~Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits."
Mount Sinai Kravis Children's Hospital, New York
Upstate Golisano Children's Hospital, Syracuse
Nemours Children's Health System - Wilmington, Wilmington
Pediatric Specialists of Virginia, Fairfax
Children's Hospital of The King's Daughters, Norfolk
University of North Carolina at Chapel Hill, Chapel Hill
Levine Children's Hospital, Charlotte
Children's Healthcare of Atlanta at Egleston/Emory University, Atlanta
Nemours Children's Health System - Jacksonville, Jacksonville
Nemours Children's Health System - Orlando, Orlando
Nicklaus Children's Hospital, Miami
Children's of Alabama, Birmingham
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville
Nationwide Children's Hospital, Columbus
Rainbow Babies & Children's Hospital, Cleveland
Cincinnati Children's Hospital Medical Center, Cincinnati
Dayton Children's Hospital, Dayton
Riley Hospital for Children, Indianapolis
University of Iowa Children's Hospital, Iowa City
Children's Hospital of Wisconsin, Milwaukee
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
Cardinal Glennon Children's Medical Center, St Louis
Children's Mercy Hospital, Kansas City
Children's Hospital and Medical Center Omaha, Omaha
Oklahoma University Medical Center, Oklahoma City
Stanford Children's Health, Alto
Yale-New Haven Children's Hospital, New Haven
MassGeneral Hospital for Children, Boston
Boston Children's Hospital, Boston
"University of Michigan , CS Mott Children's Hospital"
"St. Louis Children's Hospital , Washington University"
The University of Vermont Children's Hospital, Burlington
Patient-Centered Outcomes Research Institute
OTHER
ImproveCareNow (ICN)
OTHER
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Grifols Diagnostics Solutions, Inc
UNKNOWN
National Institutes of Health (NIH)
NIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of North Carolina, Chapel Hill
OTHER