Adalimumab Discontinuation for Uveitis

(ADJUST Trial)

Recruiting in Palo Alto (17 mi)

+27 other locations

Overseen by Nisha Acharya, MD MS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Nisha Acharya

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Research Team

Nisha Acharya, MD MS

Principal Investigator

Principal Investigator

Eligibility Criteria

This trial is for patients with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), who have been on a stable dose of adalimumab or its biosimilar for at least 6 months. Participants must be over 2 years old, have had controlled eye inflammation and arthritis for a year, agree to use effective contraception, and avoid live vaccines. Exclusions include recent NSAID eye drop use, acute uveitis symptoms, cancer history, recent corticosteroid treatment, planned eye surgery, pregnancy/lactation.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study period

I have been diagnosed with uveitis linked to juvenile arthritis or chronic anterior uveitis.

I am on a stable, low dose of specific immune system medications.

Exclusion Criteria

Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)

I have another health condition that might affect my treatment in this study.

I have severe cataracts in both eyes that block my vision.

Treatment Details

Interventions

• Adalimumab (TNF-alpha Inhibitor)
• Placebo (Other)

Trial Overview The study tests if it's possible to safely stop taking adalimumab in patients whose JIA-associated uveitis has been inactive. It's a randomized trial where participants will either continue with adalimumab or switch to a placebo without knowing which one they're getting.

Participant Groups

Group I: Continue adalimumab Active Control 1 Intervention

Patients randomized to this arm will continue adalimumab at their current weight-based dose administered subcutaneously every other week.

Group II: Stop adalimumab Placebo Group 1 Intervention

Patients randomized to this arm will receive a volume-matched placebo administered subcutaneously every other week.

Adalimumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

Nisha Acharya

Lead Sponsor

Trials

1

Recruited

90+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

Trials

146

Recruited

36,900+

Matthew Shaw

Great Ormond Street Hospital for Children NHS Foundation Trust

Chief Executive Officer since 2018

Medical degree and orthopaedic surgery specialization

Professor Sanjiv Sharma

Great Ormond Street Hospital for Children NHS Foundation Trust

Chief Medical Officer since 2024

Medical degree with extensive experience in paediatrics

Sheffield Children's NHS Foundation Trust

Collaborator

Trials

59

Recruited

6,600+

University Hospitals, Leicester

Collaborator

Trials

157

Recruited

511,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Dr. Michael F. Chiang

National Eye Institute (NEI)

Chief Executive Officer since 2020

MD from Harvard Medical School

Dr. Richard Lee

National Eye Institute (NEI)

Chief Medical Officer since 2021

MD, PhD from Harvard Medical School

Royal Children's Hospital

Collaborator

Trials

38

Recruited

232,000+