ADVISE - Protocol version 1.0 19 Dec 2018
Research type
Research Study
Full title
ADalimumab Vs. conventional ImmunoSupprEssion for uveitis (ADVISE)Trial
IRAS ID
261510
Contact name
Alastair Denniston
Contact email
Sponsor organisation
Johns Hopkins University
Eudract number
2019-002366-12
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
This study is evaluating treatments for uveitis, which is an inflammation inside of the eye. The types of uveitis being studied can cause vision loss. Treatment helps to avoid vision loss. This study compares two kinds of drugs for treatment of non-infectious uveitis that requires additional treatment to control. Both treatments are commonly used. Adalimumab also called Humira®, is approved for treatment of uveitis. The other treatment approach is conventional immunosuppression drugs that are not approved for treatment of uveitis, however they are approved for other conditions involving inflammation. Conventional immunosuppression has been shown to be effective for treatment of uveitis and is commonly used to treat uveitis. The first line treatment for uveitis is an oral corticosteroid drug like prednisone. Often a high dose of prednisone is needed to control the inflammation. Because high doses of prednisone can lead to side effects like weight gain and increased blood pressure, patients who need high doses of prednisone are often given immunosuppressive drugs to help control inflammation. Adding immunosuppressive drugs allows the dose of prednisone to be reduced over time. In this trial we are comparing conventional immunosuppressive drugs to adalimumab, a relatively new type of immunosuppressive drug. Corticosteroids and conventional immunosuppressive drugs have been used as “standard of care” treatment for uveitis but are not approved for treating uveitis. Both conventional immunosuppression and adalimumab are usually given to allow the dose of prednisone to be reduced or stopped without allowing uveitis inflammation to increase. Both adalimumab and conventional immunosuppressive drugs are effective treatments for uveitis and are used in clinical care. The purpose of this study is to find out which treatment approach works better. We will measure how well the drugs work by comparing which is better at keeping uveitis under control on lower doses of prednisone.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0568
Date of REC Opinion
8 Apr 2020
REC opinion
Further Information Favourable Opinion