Adalimumab Discontinuation for Uveitis
(ADJUST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if patients with stable uveitis related to juvenile idiopathic arthritis or chronic anterior uveitis can safely discontinue adalimumab, a medication used to control inflammation. Participants will either continue taking adalimumab or switch to a placebo (a non-active substance) to compare outcomes. The trial is designed for those who have had controlled eye inflammation and arthritis for over a year and are currently on adalimumab. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does require that any antimetabolite or topical corticosteroid doses be stable for at least 90 days before joining. It's best to discuss your specific medications with the study team.
What is the safety track record for adalimumab?
Research shows that adalimumab is generally safe for treating uveitis and other conditions. Studies indicate that it can reduce the risk of sudden worsening of symptoms, known as uveitic flares, and help improve vision. However, some patients have reported more side effects compared to those taking a placebo, which is a harmless pill with no active drug.
Patients using adalimumab might face a higher risk of serious infections, potentially requiring hospitalization. Despite these risks, the FDA has approved adalimumab for several uses, indicating that its safety has been carefully studied. While most people tolerate the drug well, discussing any concerns with a healthcare provider before joining a trial is important.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for uveitis, which often involve corticosteroids or immunosuppressive drugs, adalimumab offers a targeted approach by blocking a specific protein involved in inflammation called tumor necrosis factor (TNF). This mechanism can potentially reduce inflammation more effectively and with fewer side effects than traditional therapies. Researchers are excited about adalimumab because it is administered subcutaneously, which can be more convenient for patients compared to intravenous treatments. Additionally, adalimumab has already shown promise in managing other inflammatory conditions, offering hope for better long-term control of uveitis.
What is the effectiveness track record for adalimumab in treating uveitis?
Research has shown that adalimumab effectively treats uveitis, an eye condition that causes inflammation. One study found that adalimumab reduced swelling in the central part of the retina, known as macular edema, in 53% of patients with noninfectious uveitis. Another study reported that about 56%-66% of patients experienced success with weekly doses for eye inflammation. Long-term studies also support adalimumab's effectiveness for uveitis, demonstrating positive results over time. Its approval for treating uveitis indicates strong support from previous research. In this trial, participants will either continue adalimumab or stop it and receive a placebo, allowing researchers to assess the effects of discontinuation.15678
Who Is on the Research Team?
Nisha Acharya, MD MS
Principal Investigator
Principal Investigator
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either continue adalimumab or switch to a placebo, with biweekly administration based on weight
Follow-up
Participants are monitored for recurrence of uveitis and joint inflammation after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adalimumab
- Placebo
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Hidradenitis suppurativa
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nisha Acharya
Lead Sponsor
University of Miami
Collaborator
University of Utah
Collaborator
University of Texas at Austin
Collaborator
Vanderbilt University Medical Center
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
Sheffield Children's NHS Foundation Trust
Collaborator
University Hospitals, Leicester
Collaborator
National Eye Institute (NEI)
Collaborator
Royal Children's Hospital
Collaborator