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Trial registered on ANZCTR


Registration number
ACTRN12607000104459
Ethics application status
Approved
Date submitted
29/01/2007
Date registered
2/02/2007
Date last updated
2/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rituximab in bullous pemphigoid
Scientific title
Rituximab in the adjuvant treatment of bullous pemphigoid: a prospective open-label pilot study in three patients to study remission of disease with rituximab
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bullous pemphigoid 1598 0
Condition category
Condition code
Skin 1701 1701 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rituximab 375mg m-2 weekly for 4 weeks
Intervention code [1] 1578 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2361 0
Patients response rate
Timepoint [1] 2361 0
Measured at 1 and 3 months after rituximab administration and 3-monthly therafter until completion of study. Completion of study was at 17 months post rituximab but in one patient, follow-up was ceased at 13 months post rituximab when they demonstrated clinical remission.
Secondary outcome [1] 4113 0
Complete or partial response, reponse duration, % patients able to discontinue steroids, toxicity, reduction in skin antibody levels.
Timepoint [1] 4113 0
These secondary outcomes were measured at 1 and 3 months post rituximab and 3-monthly therafter until study completion. Completion of study was at 17 months post rituximab but in one patient, follow-up was ceased at 13 months post rituximab when they demonstrated clinical remission

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
WHO performance status >3, unable to comprehend patient information and consent form.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1845 0
Charities/Societies/Foundations
Name [1] 1845 0
Peter MacCallum Cancer Centre
Address [1] 1845 0
Country [1] 1845 0
Australia
Funding source category [2] 1846 0
Commercial sector/Industry
Name [2] 1846 0
Roche drug company
Address [2] 1846 0
Country [2] 1846 0
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1662 0
Commercial sector/Industry
Name [1] 1662 0
Roche
Address [1] 1662 0
Country [1] 1662 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3446 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 3446 0
Ethics committee country [1] 3446 0
Date submitted for ethics approval [1] 3446 0
Approval date [1] 3446 0
06/01/2004
Ethics approval number [1] 3446 0
04/15

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27512 0
Address 27512 0
Country 27512 0
Phone 27512 0
Fax 27512 0
Email 27512 0
Contact person for public queries
Name 10767 0
Professor H. Miles Prince
Address 10767 0
Chair, Haematology Services,
Peter MacCallum Cancer Centre,
Locked Bag 1, A'Beckett St, East Melbourne VIC 8006
Country 10767 0
Australia
Phone 10767 0
+61 3 96561700
Fax 10767 0
+61 3 96561408
Email 10767 0
miles.prince@petermac.org
Contact person for scientific queries
Name 1695 0
Professor H. Miles Prince
Address 1695 0
Chair, Haematology Services,
Peter MacCallum Cancer Centre,
Locked Bag 1, A'Beckett St, East Melbourne VIC 8006
Country 1695 0
Australia
Phone 1695 0
+61 3 96561700
Fax 1695 0
Email 1695 0
miles.prince@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary