Rituximab in the Treatment of Patients With Bullous Pemphigoid

NCT00286325 | Completed Phase 1 Results

• 1 other identifier: Pro00013763
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the safety of treatment of bullous pemphigoid in patients resistant to therapy with systemic corticosteroids, with rituximab plus systemic corticosteroids.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  The primary safety endpoint is the occurrence of treatment emergent adverse events including infections, infusion reactions and disease progression. These were determined by clinical evaluation and laboratory questions. Disease progression is defined as development of new blisters despite therapy. These are reported as the number of participants with a study related SAE.

  1 year

Secondary Outcomes (4)

• Number of Days to Cessation of New Blister

  1 year

• Systemic Corticosteroid Dose of 25% of Starting Dose or 10 mg/Day by Week 24

  24 weeks

• IgG Anti Bullous Pemphigoid (BP) 180 Measured in Units by ELISA at Week 24.

  Week 0 and at 24 weeks

• B Cell Number at Week 24

  Week 0 and at 24 weeks

Study Arms (1)

Treatment Rituximab

EXPERIMENTAL

Open label study all subjects treated with rituximab

Drug: Rituximab

Interventions

Rituximab DRUG

Infusion of 1000 mg of rituximab on day 0 and day 14

Also known as: rituxan

Treatment Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with autoimmune blistering skin diseases with clinical, histologic and immunological criteria confirming the diagnosis of bullous pemphigoid
• Ongoing disease activity on 17.5 mg/day of prednisone or more

You may not qualify if:

• Current use of other immunosuppressive therapy such as azathioprine, cytoxan or mycophenolate mofetil within the last 4 weeks.

Sponsors & Collaborators

• Duke University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Open label trial of rituximab in the treatment of 7 patients with the autoimmune blistering disease bullous pemphigoid.

Results Point of Contact

• Title: Dr. Russell P Hall
• Organization: Duke University Medical Center

hall0009@mc.duke.edu

919-684-3110

Study Officials

• Russell Hall, III, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: March 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 11, 2013
• Results First Posted: October 22, 2012

Record last verified: 2012-09

Locations

US (1)