CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Adalimumab +1 morebiological
Likely dose
Adalimumab 20mgfrom 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/NCT03816397
NCT03816397Phase 4Completed
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Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

Nisha Acharya·interventional·Posted Jan 25, 2019·Updated May 11, 2025

In Brief

A Phase 4 clinical trial evaluating Adalimumab and Placebo for Uveitis and JIA. Completed, enrolled 87 participants across 21 sites in 3 countries.

Detailed Summary

The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUveitis, JIA
CountriesAustralia, United Kingdom, United States
CollaboratorsChildren's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, National Eye Institute (NEI), Great Ormond Street Hospital for Children NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Royal Children's Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust, Vanderbilt University Medical Center, University of California, Davis, University of Texas at Austin, University of Miami, University Hospitals, Leicester, University of Utah, Colorado Retina Associates, Manchester University NHS Foundation Trust

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 25, 2019
Enrollment StartMar 15, 2020
Primary CompletionJan 23, 2025
Study CompletionApr 3, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.4 years ago

Interventions

Adalimumabbiological

Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8 mL and 40mg/0.8 mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient.

Placeboother

The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The volume-matched (0.8mL) placebo is designed to match the characteristics of the citrate-free adalimumab during injection.