Efficacy and Safety of Adalimumab in Active 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 as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate-, Posterior-, or Pan-uveitis

• IRAS ID

  44276

• Contact name

  Andrew Dick

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2009-016095-68

• ISRCTN Number

  N/A

• 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 active Uveitis despite being treated with a minimum of 10mg a day of steroids for 2 weeks. All subjects will also receive a high dose (60mg) of steroid which is then tapered. 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 1, 4, 6, 8 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/H0406/45

• Date of REC Opinion

  21 Sep 2010

• REC opinion

  Further Information Favourable Opinion