Efficacy and Safety of Adalimumab in Inactive Non-infectious Uveitis
Research type
Research Study
Full title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Inactive Non-infectious Intermediate-, Posterior-, or Pan-uveitis
IRAS ID
53638
Contact name
Andrew Dick
Sponsor organisation
Abbott GmbH & Co. KG
Eudract number
2009-016008-22
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Uveitis is an inflammatory disease of the eyes, with symptoms of pain, irritation, redness, swelling and loss of function. Uveitis can eventually lead to blindness and it is thought that it is responsible for about 10% of all cases of being blind. Uveitis can be caused by an infection, but most cases are non-infectious with many different possible causes including the body??s immune (defence) system going wrong or an underlying medical condition. Treatments currently available such as steroids have predictable long term side effects. There is therefore a need to develop more effective treatments. Adalimumab is a medicine that has been shown to be effective in, and is currently licensed for, treating other illnesses which have inflammation (response of the body to injury or irritation; characterized by pain, swelling, redness, heat processes and eventual loss of function) as the main cause. Since non infectious Uveitis has a similar underlying mechanism of disease, it is thought that adalimumab may be effective in its treatment. This study will compare adalimumab against placebo (placebo looks the same as adalimumab but contains no active drug). Subjects must have inactive Uveitis when entering the study but must be taking 10-35 mg steroid per day to control their disease and be unable to stop steroid treatment without symptoms reappearing. All subjects will be tapered off steroids once they have started study treatment. Subjects will attend regular study visits at hospital. Each subject could be in the study for up to 84 weeks depending on treatment response, with visits for screening, baseline, week 2, 4 and then every 4 weeks. Subjects will receive study medication from baseline on. The effect of the treatment on the eyes will be checked by having blood tests, eye assessments, recording ongoing medical history, and completing questionnaires.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
10/H0406/46
Date of REC Opinion
21 Sep 2010
REC opinion
Further Information Favourable Opinion