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Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid
This study is not yet open for participant recruitment.
Verified by University of Alabama at Birmingham, December 2007
Sponsors and Collaborators: University of Alabama at Birmingham
Genentech
Biogen Idec
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584935
  Purpose

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
Ocular Cicatricial Pemphigoid
Drug: Rituximab
Phase I
Phase II

Drug Information available for: Rituximab
U.S. FDA Resources
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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 1. No evidence of further scarring (Fosters Staging) at 16 weeks
  • 2. The proportion of patients that experience a Grade 3, Grade 4, or Grade 5 toxicity based reaction on the NCI-CTC system at the time of their infusions and during follow-up visits.

Secondary Outcome Measures:
  • 1. Stability of visual acuity (Snellen's Test) at 16 weeks
  • 2. Stability of visual acuity (Snellen's Test) at 24 weeks
  • 3. Decreased requirement for conventional medications at 16 weeks.

Estimated Enrollment: 5
Study Start Date: January 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of ocular cicatricial pemphigoid (symptoms of conjuctivitis, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584935

Contacts
Contact: Wendy Cantrell, CRNP 205-502-9960 wcantrell@uabmc.edu
Contact: Craig A. Elmets, M.D. 205-934-5188 celmets@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Genentech
Biogen Idec
Investigators
Principal Investigator: Craig A Elmets University of Alabama at Birmingham
  More Information

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

Keywords provided by University of Alabama at Birmingham:
Pemphigoid
Blistering Diseases
Blindness
Autoimmune
Rituximab

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009