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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Kirsty
Lanyon
+44 (0)117 455 1343
astute-trial@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Autoimmune non-infectious uveitis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Autoimmune uveitis is a term for several rare eye diseases in which the body’s own immune system causes sight-threatening damage to the light sensitive retina at the back of the eye. Uveitis causes sight loss from inflammation inside the eye, damage to blood vessels in the retina or leakage of fluid into the central, most sensitive area of the retina. Two in 10,000 people are at risk of serious sight loss from uveitis. Usual treatment for autoimmune uveitis involves low dose steroids and one or two other drugs to reduce inflammation. Unfortunately, many patients do not respond to or tolerate usual treatment, or they need high dose steroids to control the uveitis. Long term high dose steroids increase the risk of heart attack, stroke, and infection and affect physical and mental health. Adalimumab is a drug that targets chemicals released by inflamed tissue, neutralising their damage to the body. This study aims, first, to identify patients who are most likely to benefit from adalimumab. Then, in patients who are successfully treated with adalimumab and low dose steroids, a randomised controlled trial will be conducted to compare adalimumab and placebo.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38267244/ (added 25/01/2024)
You can take part if:
Current inclusion criteria as of 21/11/2023:
1. Aged 18 years or over
2. Participant has:
2.1. Active sight-threatening ANIU (active inflammatory chorioretinal lesions OR abnormal central macular thickness (CMT) OR evidence of retinal vasculitis OR vitreous haze >0.5) and is being prescribed (already taking or being started on, if newly presenting with ANIU) oral prednisolone >5.0 mg/day; OR
2.2. Has controlled ANIU and is being prescribed oral prednisolone >5.0 mg/day.
3. Women must have a negative pregnancy test and be willing to use effective contraception for the duration of the participation in the trial and for 5 months after, or be surgically sterile or post-menopausal for >12 months
4. Able to provide
You may not be able to take part if:
Current participant exclusion criteria as of 06/07/2022:1. Participant has controlled ANIU and is maintained on oral prednisolone ≤5.0mg/day at the time of screening 2. Participant has systemic disease (whether associated with ANIU or not) that is being treated with steroids and requires >5mg/day oral prednisolone 3. Participant has untreated or active tuberculosis4. Participant has severe infection, sepsis, or opportunistic infection5. Participant has uncontrolled glaucoma 6. Participant has multiple sclerosis 7. Participant is HIV positive 8. Participant has hepatitis B or hepatitis C 9. Participant has syphilis10. Participant has Lyme disease11. Participant has Behcet’s disease12. Participant has toxoplasmosis chorioretinitis13. Participant has heart failure (NYHA III/IV)14. Participant has been diagnosed with cancer <5 years ago15. Participant is undergoing monitoring for recurrence of cancer/tumour growth where their oncologist has concern that a TNFalpha inhibitor would be contraindicated16. Participant is taking another biologic drug17. Participant has taken an anti-TNF drug within the previous 90 days (anakinra and abatacept are contraindicated); 18. Participant has had an Iluvien® implant within the previous 18 months and has controlled ANIU, or has had an Iluvien® implant within the previous 12 weeks regardless of whether ANIU is active or controlled19. Participant has had an Ozurdex® implant, or an intravitreal steroid injection, or periocular steroid within the previous 12 weeks regardless of whether ANIU is active or controlled20. Participant is pregnant21. Participant has a known allergy or hypersensitivity to adalimumab or any of its excipients22. Participant is taking part in another interventional study23. Participant has an epiretinal membrane likely to prevent an eye meeting response criterion at 16 weeks of central macular thickness <320um
Previous exclusion criteria as of 08/06/2020:1. Participant has controlled ANIU and is maintained on CS ≤5.0mg/day at the time of screening2. Participant has untreated or active tuberculosis3. Participant has severe infection, sepsis or opportunistic infection4. Participant has uncontrolled glaucoma5. Participant has multiple sclerosis6. Participant is HIV positive7. Participant has hepatitis B or hepatitis C8. Participant has syphilis9. Participant has Lyme disease10. Participant has Behcet's disease11. Participant has heart failure (NYHA III/IV;12. Participant has been diagnosed with cancer <5 years ago13. Participant is undergoing monitoring for recurrence of cancer/tumour growth where their oncologist has concern that a TNFalpha inhibitor would be contraindicated14. Participant is taking another biologic drug15. Participant has taken an anti-TNF drug within the previous 90 days (anakinra and abatacept are contraindicated)16. Participant has an ocular CS implant within the previous 12 months or an intravitreal steroid injection within the previous 3 months17. Participant is pregnant18. Participant has a known allergy or hypersensitivity to adalimumab or any of its excipients19. Participant is taking part in another interventional study
_____
Previous exclusion criteria:1. Controlled ANIU and is maintained on CS less than or equal to 5.0 mg/day at the time of screening2. Untreated or active tuberculosis3. Severe infection, sepsis or opportunistic infection4. Uncontrolled glaucoma5. Multiple sclerosis6. HIV positive7. Hepatitis B or hepatitis C8. Behcet’s disease9. Heart failure (NYHA III/IV)10. No history of varicella or does not have varicella antibodies11. Taking another biologic drug12. Taken an anti-TNF drug within the previous 90 days (anakinra and abatacept are contraindicated)13. Ocular CS implant within the previous 12 months or an intravitreal steroid injection within the previous 3 months14. Pregnant15. Known allergy or hypersensitivity to adalimumab or any of its excipients16. Taking part in another interventional study
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Kirsty
Lanyon
+44 (0)117 455 1343
astute-trial@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University Hospitals Bristol and Weston NHS Foundation Trust and funded by National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 45139
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
