Trial record 1 of 2 for:    "Ocular cicatricial pemphigoid"
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Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

This study has been completed.
Sponsor:
Collaborators:
Genentech
Biogen Idec
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584935
First received: December 26, 2007
Last updated: August 5, 2011
Last verified: August 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • 2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: January 2006
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).
    Other Name: Rituximab
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

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

No publications provided

Responsible Party: Craig Elmets, M.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584935     History of Changes
Other Study ID Numbers: F060213003
Study First Received: December 26, 2007
Results First Received: February 15, 2011
Last Updated: August 5, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pemphigoid, Benign Mucous Membrane
Pemphigoid, Bullous
Conjunctival Diseases
Eye Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014