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NCT02772965 · ClinicalTrials.gov registry record · Phase 3
Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
A Phase 3 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 3
- Development phase
- 306
- Enrollment target
NCT02772965: Completed Phase 3 study, sponsored by University of North Carolina, Chapel Hill.
NCT02772965 is a Phase 3 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 306 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02772965, a Phase 3 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 306 participants
- Enrollment target
Study 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.
Primary Outcome
Treatment failure is defined as follows: 1. Failure to achieve remission (short pediatric Crohn's disease activity index \[SPCDAI\] \< 15) by the week 26 visit; 2. If study initiated on steroids, failure to complete steroid taper by week 16; 3. Short pediatric Crohn's disease activity index (SPCDAI) ≥ 15 attributed to active Crohn's disease, at two or more consecutive visits beyond the week 26 visit. Elevated SPCDAI (≥ 15) due to a non-Inflammatory Bowel Disease (IBD) reason does not count towa
Interventions
- DRUG Methotrexate
- OTHER Sugar pill (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2016-10 |
| Est. Completion | 2022-04-07 |
| Phase | Phase 3 |
What the finished NCT02772965 record still lists
NCT02772965 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Methotrexate is the first listed.
NCT02772965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02772965 about?
NCT02772965 is a clinical study titled "Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy". 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.
What is the current status of trial NCT02772965?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2016-10. Estimated completion is 2022-04-07.
What interventions are being tested in trial NCT02772965?
The interventions under investigation include: Methotrexate (DRUG), Sugar pill (placebo) (OTHER).
Who is sponsoring clinical trial NCT02772965?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02772965's enrollment target sits among peer trials
306 1115th of 2000 higher than 884 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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