Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
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.
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
Study identification
- NCT ID
- NCT02772965
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- University of North Carolina, Chapel Hill
- Other
- Enrollment
- 306 participants
Conditions and interventions
Conditions
Interventions
- Methotrexate Drug
- Sugar pill (placebo) Other
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
- Sep 30, 2016
- Primary completion
- Apr 6, 2022
- Completion
- Apr 6, 2022
- Last update posted
- Apr 11, 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 11, 2023 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02772965 live on ClinicalTrials.gov.