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Sponsors and Collaborators: |
University of Alabama at Birmingham Genentech Biogen Idec |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00584935 |
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. Ritumimab 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.
Condition | Intervention | Phase |
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Ocular Cicatricial Pemphigoid |
Drug: Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid |
Estimated Enrollment: | 5 |
Study Start Date: | January 2006 |
Cicatricial pemphigoid is an autoimmune blistering disease whcih can affect the skin, mucous membranes, and, in a small subset of patients, the eyes. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments have included high dose systemic steroids, dapsone, and immunosuppressive agents such as azathioprine, methotrexate, cyclophosphamide, and mycophenolate mofetil. However, there are a subgroup of patients who fail to respond to these treatments, develop intolerable side effects, or have contraindications to their use. Patients may also develop resistance to these conventional treatment modalities. For these reasons, alternative treatment modalities are needed. Rituximab has been very effective in the treatment of other autoimmune disorders. It has recently been shown to be effective in the treatment of another autoimmune blistering disorder known as pemphigus. We thus propose that Rituximab will be effective in the treatment of cicatricial pemphigoid.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following:
Exclusion Criteria:
Contact: Wendy Cantrell, CRNP | 205-502-9960 | wcantrell@uabmc.edu |
Contact: Craig A. Elmets, M.D. | 205-934-5188 | celmets@uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Craig A Elmets | University of Alabama at Birmingham |
Study ID Numbers: | U3441S |
Study First Received: | December 26, 2007 |
Last Updated: | December 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00584935 |
Health Authority: | United States: Food and Drug Administration |
Pemphigoid Blistering Diseases Blindness Autoimmune Rituximab |
Pemphigoid, Bullous Ocular cicatricial pemphigoid Autoimmune Diseases Benign mucosal pemphigoid Skin Diseases, Vesiculobullous Skin Diseases |
Rituximab Bullous pemphigoid Cicatricial pemphigoid Pemphigoid, Benign Mucous Membrane Blindness Blister |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |