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Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
NCT02065557 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02065557
The ClinicalTrials.gov registry entry for NCT02065557 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02065557 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Georgia, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02065557?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Placebo (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02065557?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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