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NCT02065557 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT02065557: Completed Phase 3 study of Ulcerative Colitis, sponsored by AbbVie.
NCT02065557 is a Phase 3 study of Ulcerative Colitis that has completed, run by AbbVie. The registered enrollment target is 101 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065557, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
Primary Outcome
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.
Conditions Studied
Interventions
- BIOLOGICAL Adalimumab
- BIOLOGICAL Placebo
Study Locations (20)
California
- Childrens Hospital LA /ID# 147452 - Los Angeles
- Univ California, San Francisco /ID# 120901 - San Francisco
Georgia
- Emory University Hospital /ID# 121858 - Atlanta
- Children's Ctr Digestive, US /ID# 121855 - Atlanta
Illinois
- University of Chicago /ID# 120904 - Chicago
- Loyola University Medical Ctr /ID# 120900 - Maywood
Massachusetts
- Massachusetts General Hospital /ID# 124551 - Boston
- Boston Childrens Hospital /ID# 147714 - Boston
Minnesota
- Mayo Clinic - Rochester /ID# 121056 - Rochester
- Minnesota Gastroenterology P.A /ID# 120895 - Saint Paul
New York
- North Shore University Hospital /ID# 120905 - New Hyde Park
- Univ Rochester Med Ctr /ID# 127776 - Rochester
Florida
- Arnold Palmer Hosp Children /ID# 120898 - Orlando
Indiana
- Indiana University /ID# 120908 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2014-10-13 |
| Est. Completion | 2020-02-07 |
| Phase | Phase 3 |
What the finished NCT02065557 record still lists
NCT02065557 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Adalimumab is the first listed.
NCT02065557 names 20 study sites across 14 states, led by California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT02065557 about?
NCT02065557 is a clinical study titled "Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis". The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
What is the current status of trial NCT02065557?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2014-10-13. Estimated completion is 2020-02-07.
What conditions does trial NCT02065557 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT02065557?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02065557?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02065557 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02065557's enrollment target sits among peer trials
101 66th of 122 higher than 57 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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