Adalimumab vs. Conventional Immunosuppression for Uveitis Trial (NCT03828019) | Clinical Trial Compass
CompletedPhase 3
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
United States, Australia, United Kingdom227 participantsStarted 2019-09-16
Plain-language summary
Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-tumor necrosis(TNF)-α monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 13 years or older
. Weight 30 kg (66 lbs) or greater
. Active or recently active (≤ 60 days) non-infectious intermediate, posterior, or panuveitis
. Prednisone indication meets one of the following:
. Active uveitis requiring one of the following i. Initiation of prednisone at dose greater than 7.5 mg/day ii. Increasing prednisone dose to greater than 7.5 mg/day iii. Currently receiving dose greater than 7.5 mg/day
. Inactive uveitis on current dose greater 7.5 mg/day
. Initiation or addition of an immunosuppressive drug (i.e., a conventional immunosuppressive drug or adalimumab) is indicated
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization
. If currently receiving a conventional immunosuppressive drug, the drug and dose have been stable for at least 30 days
Exclusion criteria
. Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-γ release assay \[Interferon-gamma release assay (IGRA) test, such as Quantiferon-gold)
. Untreated active hepatitis B or C infection
. Any of the following baseline lab values
. White blood count \<3500 cells per microliter
. Platelets \<100,000 per microliter
. Hematocrit \<30%
. aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.5 times (X) upper limit normal value
. Serum creatinine \>1.1 times (X) upper limit normal value