CompletedPhase 4ACTRN12607000104459

Rituximab in bullous pemphigoid

Rituximab in the adjuvant treatment of bullous pemphigoid: a prospective open-label pilot study in three patients to study remission of disease with rituximab


Sponsor

Peter MacCallum Cancer Centre

Enrollment

3 participants

Start Date

Jan 1, 2005

Study Type

Interventional

Conditions

Summary

Rituximab has been used extensively for the treatment of other immune diseases and for a blood cancer, lymphoma. This trial is to determine if rituximab is also effective in the treatment of bullous skin diseases such as bullous pemphigoid. We want to assess if rituximab is a good alternative to other standard treatments for bullous pemphigoid including immune suppressive drugs, or if it can be effective in those patients that have not responded or are intolerant to either steroid treatment or immune suppressive treatment. The aim of this trial is to determine if there is any improvement in the skin lesions or if the dose of steroids or immune suppressive drugs can be reduced. Rituximab is only currently approved in Australia for the use in lymphoma and is not currently approved for the use in bullous skin disease. Rituximab will be administered as four doses, each a week apart and then patient assessment will take place at 1 month and 3 months post treatment and 3-monthly thereafter to assess response


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria1

  • No severe infection requiring systemic antibiotics, failed to respond to systemic steroids or requiring doses of >10mg prednisolone per day or requiring systemic immunosuppression or unable to tolerate oral steroids.

Exclusion Criteria1

  • WHO performance status >3, unable to comprehend patient information and consent form.

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Interventions

Rituximab 375mg m-2 weekly for 4 weeks

Rituximab 375mg m-2 weekly for 4 weeks


Locations(1)

Australia

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ACTRN12607000104459


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