Long Term Safety and Efficacy of Adalimumab in Non-infectious Uveitis

• Research type

  Research Study

• Full title

  A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

• IRAS ID

  53684

• Contact name

  Andrew Dick

• Sponsor organisation

  AbbVie Deutschland GmbH & Co.KG

• Eudract number

  2009-016196-29

• 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 look at whether or not adalimumab works to treat Uveitis symptoms over the long term and the long term safety profile of the drug. Subjects can only enter this study if they have already completed one of the 2 Abbott sponsored studies (M10-877 or M10-880) that compare adalimumab versus placebo (placebo looks the same as adalimumab but contains no active drug). Subjects will attend regular study visits at hospital. Each subject could be in the study for up to 78 weeks depending on treatment response, with visits for baseline, week 2, 4, 8, 12, 18 and then every 12 weeks. Subjects will receive adalimumab 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/H0406/47

• Date of REC Opinion

  21 Sep 2010

• REC opinion

  Further Information Favourable Opinion