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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02772965

Public ClinicalTrials.gov record NCT02772965. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02772965
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
306 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
Up to 20 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2016 (Type not available)
Primary completion
Apr 7, 2022 (Actual)
Completion
Apr 7, 2022 (Actual)
Last update posted
Apr 12, 2023

2016 – 2022

United States locations

U.S. sites
32
U.S. states
21
U.S. cities
30
Facility City State ZIP Site status
Children's of Alabama Birmingham Alabama 35233 —
Stanford Children's Health Alto California 94304 —
Yale-New Haven Children's Hospital New Haven Connecticut 06510 —
Nemours Children's Health System - Wilmington Wilmington Delaware 19803 —
Nemours Children's Health System - Jacksonville Jacksonville Florida 32207 —
Nicklaus Children's Hospital Miami Florida 33155 —
Nemours Children's Health System - Orlando Orlando Florida 32827 —
Children's Healthcare of Atlanta at Egleston/Emory University Atlanta Georgia 30329 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Riley Hospital for Children Indianapolis Indiana 46202 —
University of Iowa Children's Hospital Iowa City Iowa 52242 —
MassGeneral Hospital for Children Boston Massachusetts 02114 —
Boston Children's Hospital Boston Massachusetts 02115 —
University of Michigan | CS Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Mercy Hospital Kansas City Missouri 64108 —
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 —
St. Louis Children's Hospital | Washington University St Louis Missouri 63110 —
Children's Hospital and Medical Center Omaha Omaha Nebraska 68114 —
Mount Sinai Kravis Children's Hospital New York New York 10029 —
Upstate Golisano Children's Hospital Syracuse New York 13210 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 —
Levine Children's Hospital Charlotte North Carolina 28203 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Rainbow Babies & Children's Hospital Cleveland Ohio 44106 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Dayton Children's Hospital Dayton Ohio 45404 —
Oklahoma University Medical Center Oklahoma City Oklahoma 73104 —
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232 —
The University of Vermont Children's Hospital Burlington Vermont 05401 —
Pediatric Specialists of Virginia Fairfax Virginia 22031 —
Children's Hospital of The King's Daughters Norfolk Virginia 23507 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02772965, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2023 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02772965 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →