Clinical Trial: Gevokizumab for Active Scleritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition (GATSBY)

Brief Summary:

Background:

- Scleritis is the inflammation of the white outer coating of the eye, known as the sclera. In severe cases, it can cause blindness. It is commonly associated with autoimmune disorders such as rheumatoid arthritis. Mild scleritis can be treated with drugs such as ibuprofen. More severe scleritis may need oral steroids or immunosuppressive treatments; however, these treatments can cause side effects in the whole body. Gevokizumab is a newer anti-inflammatory drug that is under investigation to treat other inflammatory diseases. It may not have as severe side effects as some other drugs. However, it has not yet been used to treat scleritis. Researchers want to see if it can be given as a safe and effective treatment for scleritis.

Objectives:

- To see if gevokizumab is a safe and effective treatment for scleritis.

Eligibility:

- Individuals at least 18 years of age who have active scleritis.

Design:

  • There is an initial phase and a two-part extension phase in this study. The extension phase is optional. The initial phase of the study requires seven visits to the National Eye Institute (NEI).
  • Participants will be screened with a physical exam and eye exam, and medical history will be obtained. Blood and urine samples will be collected.
  • Eligible participants will receive an injection of 60 mg of gevokizumab at the first study visit and at Weeks 4, 8, and 12. They will be given under the skin by the stomach, or in the upper arm or thigh.