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TNF-alpha Inhibitor

Adalimumab Discontinuation for Uveitis (ADJUST Trial)

Phase 4

Waitlist Available

Led By Nisha Acharya, MD MS

Research Sponsored by Nisha Acharya

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥180 days on a stable dose of adalimumab or a biosimilar; must be biweekly dose of either 20mg (if<30kg) or 40mg (if ≥30kg)

Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology

Must not have

Severe cataract or opacity preventing view to the posterior pole in both eyes

Intraocular surgery in the past 90 days or planned surgery in the next 180 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until 12 months post-randomization

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if people with quiescent uveitis can stop taking adalimumab treatment without their uveitis returning.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Adalimumab can cause injection site reactions like pain or swelling; infections; headaches; rash; nausea; and potentially serious side effects such as immune system problems that could lead to more severe infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of adalimumab or its equivalent for at least 6 months.

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

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I agree not to get any live vaccines.

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I can safely receive adalimumab according to its product guidelines.

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I have been treated with adalimumab or its equivalent for at least 12 months.

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I have been using a biosimilar of adalimumab for at least 90 days.

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

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I am at least 2 years old.

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I use ≤2 drops of a mild eye steroid daily and have for over 3 months.

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My eye inflammation has been under control for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I haven't had eye surgery in the last 3 months and don't plan to in the next 6 months.

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I have red eyes with symptoms like floaters, pain, and sensitivity to light.

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I have a history of cancer, tuberculosis, or hepatitis B.

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I have had side effects from adalimumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until 12 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until 12 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 12 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to treatment failure

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Continue adalimumabActive Control1 Intervention

Patients randomized to this arm will continue adalimumab at their current dose (either 20mg/0.2mL or 40mg/0.4mL) administered subcutaneously every other week.

Group II: Stop adalimumabPlacebo Group1 Intervention

Patients randomized to this arm will receive a volume-matched placebo (0.8mL) administered subcutaneously every other week.

0 / 15Eligibility criteria met