CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 101 enrolled
Drug / intervention
Adalimumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02065557
NCT02065557Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

AbbVie·interventional·Posted Feb 19, 2014·Updated Oct 5, 2020

In Brief

A Phase 3 clinical trial evaluating Adalimumab and Placebo for Ulcerative Colitis. Completed, enrolled 101 participants across 60 sites in 14 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Austria, Belgium, Canada, Czechia, Hungary, Israel, Japan, New Zealand, Poland, Slovakia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartOct 13, 2014
Primary CompletionFeb 7, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.4 years ago

Interventions

Adalimumabbiological

Subcutaneous (SC) injection

Placebobiological

Subcutaneous (SC) injection