Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments include systemic steroids, dapsone, and immunosuppressive agents. These treatments, however, are not successful with all patients. Rituximab has been very effective in the treatment of other autoimmune disorders, and has recently been shown to be effective for autoimmune blistering pemphigus. We propose that it will also be effective in the treatment of cicatricial pemphigoid.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Biogen; Genentech, Inc.
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. Clinical diagnosis of ocular cicatricial pemphigoid (symptoms of conjunctivitis, irritation, burning, increased lacrimation, photophobia, dryness of the eyes along with conjunctival inflammation, trichiasis, and scarring

2. One of the following:

• Failed response to the use of one or more conventional treatments for a minimum of 10 weeks; or

• Minimal conventional medication doses, with a significant adverse effects, contradiction to use, or progressive disease despite treatment

3. Adults age 19 and older

4. Adequate renal function as indicated by serum creatinine levels less than 1.5

Exclusion Criteria:

1. known hypersensitivity to rituximab or its components

2. Age less than 19 years

3. Any other condition deemed by the investigator to be a significant hazard to the subject if the investigational therapy were initiated.