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Adalimumab vs. Conventional Immunosuppression for Uveitis (ADVISE Trial)
ADVISE Trial Summary
This trial is testing whether a new drug, adalimumab, is better than existing treatments for a chronic, potentially blinding disease.
ADVISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADVISE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ADVISE Trial Design
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Who is running the clinical trial?
Media Library
- I can give myself injections or have someone who can.I have had recent eye inflammation not caused by an infection.I weigh at least 66 lbs (30 kg).I am currently taking more than one drug to suppress my immune system, not counting oral steroids.You have had a bad reaction to or the medication adalimumab did not work for you in the past.I am currently being treated with a type of chemotherapy.My immunosuppressive medication dose has been stable for over a month.I have an active hepatitis B or C infection that hasn't been treated.I have had a long-acting eye steroid implant in the last 3 years, unless my uveitis is still active.I weigh at least 66 lbs (30 kg).I need to start or add an immunosuppressive medication.I am a male from the UK and will use condoms for 6 months after treatment. My partner will also use contraception.I do not have active or untreated latent tuberculosis.I am using a highly effective method of birth control.You are allergic to any of the medications or their ingredients used in the study.I have an immune system disorder that makes certain treatments unsafe for me.I can assess activity in at least one eye if I have back-of-the-eye disease.I have severe heart failure.I have been diagnosed with Behçet's disease.I currently have cancer.I have had recent eye inflammation not caused by an infection.I am taking more than 7.5 mg/day of prednisone for my uveitis.I have not received a live vaccine in the last 30 days.I am 13 years old or older.I am 13 years old or older.I am taking more than 7.5 mg/day of prednisone for my uveitis.My MRI shows signs of demyelinating disease, and I have uveitis without systemic disease.I've had corticosteroid eye injections for uveitis in the last 30 days.You are pregnant or breastfeeding.My eye inflammation is under control with medication over 7.5 mg/day.I have multiple sclerosis or a similar condition.I have a severe infection that is not under control.I haven't used anti-TNF therapy in the last 60 days.My condition requires treatment with steroids or immunosuppressants.I can see clearly with at least one eye if I have back-of-the-eye inflammation.Visual acuity of light perception or better in at least one eye.
- Group 1: Adalimumab (ADA)
- Group 2: Conventional immunosuppression (CON)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any unfilled slots in this clinical trial?
"The listed clinical trial on clinicaltrials.gov is searching for participants. The posting dates for this study were September 17th, 2019 and June 16th, 2022 respectively."
What do we know about CON from other previous clinical trials?
"At the moment, 513 clinical studies are underway which focus on Conventional immunosuppression (CON). Out of these CON trials, 112 have progressed to Phase 3. Most investigations into Conventional immunosuppression (CON) originate from Philadelphia, but there are 11,025 research centres spread out across the globe looking into this topic."
Where are the trial sites for this experiment?
"University of California, San Francisco in San Francisco, California, Tennessee Retina in Nashville, Tennessee, and University of Iowa in Iowa City, Iowa are a few example locations where this trial is taking place. In total, there are 21 sites running this study."
What is the mortality rate associated with CON treatment?
"There is some efficacy data and multiple rounds of safety data available for Conventional immunosuppression (CON), so it received a score of 3."
What is the standard treatment that Conventional immunosuppression (CON) is used for?
"Ocular rosacea is most often treated with immunosuppressive drugs, which are also sometimes used to manage transplant patients, those with small cell lung cancer, and people suffering from dermatitis or atopic conditions."
How many people are involved in the research project?
"The clinicaltrials.gov website has the latest information on this study, which is currently looking for 222 participants at 21 sites. The trial was first posted on September 17th, 2019 and was last updated on June 16th, 2020."
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