Clinical Trial: Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

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

Official Title: Phase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

Brief 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. 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.

Detailed Summary: 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.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome:

  • Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks [ Time Frame: 16 weeks ]

    Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth)

    1. 0-25%
    2. 25-50%
    3. 50-75%
    4. 75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by sympblephara and n is the number of symblephara countable)

    a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe

  • 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. [ Time Frame: 16 weeks ]


Original Primary Outcome:

  • 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.


Current Secondary Outcome:

  • 1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks [ Time Frame: 16 weeks ]
  • 2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks [ Time Frame: 24 weeks ]


Original Secondary Outcome:

  • 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.


Information By: University of Alabama at Birmingham

Dates:
Date Received: December 26, 2007
Date Started: January 2006
Date Completion:
Last Updated: August 5, 2011
Last Verified: August 2011