Adalimumab Discontinuation for Uveitis

(ADJUST Trial)

Recruiting at 27 trial locations

Overseen By Nisha Acharya, MD MS

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Nisha Acharya

Must be taking: Adalimumab

Must not be taking: Oral corticosteroids

Disqualifiers: Intraocular surgery, Cancer, Tuberculosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

87 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue adalimumab or switch to a placebo, with biweekly administration based on weight

48 weeks

Biweekly visits for administration

Follow-up

Participants are monitored for recurrence of uveitis and joint inflammation after treatment

4 weeks

Treatment Details

Interventions

• Adalimumab
• Placebo

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 European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Humira for:

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

Approved in United States as Humira for:

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

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+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator

Trials

146

Recruited

36,900+

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+

Royal Children's Hospital

Collaborator

Trials

38

Recruited

232,000+