Trial of Rituximab for Graves' Ophthalmopathy

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rebecca Bahn
• Collaborators: National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

Criteria

Inclusion Criteria:

• Patients with clinical activity score (CAS) of ≥4 and moderate to severe disease severity, as defined by thyroid eye disease severity scale based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) score

• Euthyroid for at least 6-8 weeks

• No immediate need for decompression surgery

• With disease progression over the previous 1-2 months or without evident improvement in the prior 6 months.

Exclusion Criteria:

• Corticosteroid use in the preceding 4 weeks

• HIV, hepatitis C or hepatitis B infections

• Denied consent for HIV or hepatitis testing

• Mild or inactive Graves' ophthalmopathy

• Orbital radiotherapy within 18 months or orbital surgery within the past year

• Absolute neutrophil count < 1,500/mm^3

• Pregnant or nursing patients

• Coronary artery disease, congestive heart failure, significant arrhythmias, significant infection or immunodeficiency, other serious illnesses