None listed
Conditions
Brief 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
Interventions
Rituximab 375mg m-2 weekly for 4 weeks
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
WHO performance status >3, unable to comprehend patient information and consent form.
Outcome results
None listed