Clinical Trial Evaluating Rituximab in Ocular Cicatricial Pemphigoid

Ocular Cicatricial Pemphigoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584935
• Other study ID #: F060213003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 26, 2007
• Last updated: January 11, 2018
• Start date: January 2006
• Est. completion date: May 2010

Study information

• Verified date: January 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Cicatricial pemphigoid is an autoimmune blistering disease which 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Cicatricial Pemphigoid
• Pemphigoid, Bullous

Intervention

Drug:
• Rituximab
The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15).

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Biogen, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks	Stages Characteristics I Subconjunctival scarring and fibrosis II Fornix foreshortening (a-d describes % loss of inferior fornix depth); 0-25%; 25-50%; 50-75%; 75-100% III Presence of symblepharon and number (n) (a-d describes % of horizontal involvement by symblepharons and n is the number of symblepharons countable); a. 0-25% b. 25-50% c. 50-75% d. 75-100% IV Ankyloblepharon, frozen globe	16 weeks
Primary	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.		16 weeks
Secondary	1. Stability of Visual Acuity (Snellen's Test) at 16 Weeks		16 weeks
Secondary	2. Stability of Visual Acuity (Snellen's Test) at 24 Weeks		24 weeks