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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until 12 months post-randomization
Awards & highlights
ADJUST 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.Check my eligibility
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.See study design
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.
ADJUST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ADJUST Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to treatment failure
ADJUST 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.
Find a Location
Who is running the clinical trial?
University of Texas at AustinOTHER
350 Previous Clinical Trials
80,866 Total Patients Enrolled
University of MiamiOTHER
898 Previous Clinical Trials
409,533 Total Patients Enrolled
University of UtahOTHER
1,095 Previous Clinical Trials
1,775,467 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I agree not to get any live vaccines.I have been on a stable dose of adalimumab or its equivalent for at least 6 months.I have another health condition that might affect my treatment in this study.My arthritis has been under control for at least 12 months, as confirmed by a specialist.I have severe cataracts in both eyes that block my vision.I can safely receive adalimumab according to its product guidelines.I have been treated with adalimumab or its equivalent for at least 12 months.I have been using a biosimilar of adalimumab for at least 90 days.I haven't had eye surgery in the last 3 months and don't plan to in the next 6 months.I have used NSAID eye drops in the last 90 days.I have red eyes with symptoms like floaters, pain, and sensitivity to light.I have a history of cancer, tuberculosis, or hepatitis B.I have not taken oral corticosteroids or had corticosteroid eye injections in the last year.I am at least 2 years old.I have had low eye pressure for at least 3 months.I use ≤2 drops of a mild eye steroid daily and have for over 3 months.My eye inflammation has been under control for at least 12 months.I have had side effects from adalimumab.I was diagnosed with juvenile arthritis before I turned 16.My doctor thinks I can safely continue treatment with adalimumab or a placebo.
Research Study Groups:
This trial has the following groups:- Group 1: Continue adalimumab
- Group 2: Stop adalimumab
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a survey of past research involving adalimumab?
"Currently, 50 studies are running for Continue adalimumab. Among these trials, 14 have advanced to Phase 3 and the majority of them can be found in London. Across 2044 locations, patients will find clinical trial sites recruiting participants for this therapy."
Answered by AI
Has the FDA sanctioned the use of adalimumab?
"There is ample evidence to suggest that adalimumab is a safe drug, so it received an assessment of 3."
Answered by AI
What therapeutic purposes is Continue adalimumab commonly used for?
"The application of adalimumab is effective in treating ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis."
Answered by AI
How many participants are currently being recruited for the experiment?
"Yes, the most recent information available online confirms that this clinical trial is actively recruiting participants. The study was first made public on March 15th 2020 and underwent its last update on March 9th 2022. 118 patients will be recruited from 13 different medical sites."
Answered by AI
Are there any remaining openings for individuals to join the clinical research?
"According to data on clinicaltrials.gov, this research is looking for participants as of now. It first appeared online on March 15th 2020 and was last updated a few days ago on the 9th of March 2022."
Answered by AI
What is the geographic reach of this clinical trial?
"A total of 13 clinical sites are taking part in this study, such as the University of California at Davis (Sacramento), Seattle Children's Hospital (Seattle) and Vanderbilt University Medical Center(Nashville). Additionally, there are 10 other trial locations."
Answered by AI
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