Overview

Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Children's Hospital Medical Center, Cincinnati
Grifols Diagnostics Solutions, Inc
ImproveCareNow (ICN)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
Patient-Centered Outcomes Research Institute
The Leona M. and Harry B. Helmsley Charitable Trust
Treatments:
Folic Acid
Methotrexate
Ondansetron
Vitamin B Complex