Adalimumab in JIA-associated Uveitis Stopping Trial

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).

Conditions

• Uveitis
• JIA

Interventions

BIOLOGICAL

Adalimumab

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.

OTHER

Placebo

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• Alder Hey Children's NHS Foundation Trust

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Sheffield Children's NHS Foundation Trust

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Royal Children's Hospital

  collaborator OTHER

• Norfolk and Norwich University Hospitals NHS Foundation Trust

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Texas at Austin

  collaborator OTHER

• University of Miami

  collaborator OTHER

• University Hospitals, Leicester

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Colorado Retina Associates

  collaborator UNKNOWN

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Nisha Acharya

  lead OTHER

Principal Investigators

• Nisha Acharya, MD MS · Principal Investigator

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-15

Primary Completion

2025-01-23

Completion

2025-04-03

FDA Drug

Yes

Countries

• United States
• Australia
• United Kingdom

Study Locations