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Trial registered on ANZCTR
Registration number
ACTRN12606000495527
Ethics application status
Approved
Date submitted
27/11/2006
Date registered
1/12/2006
Date last updated
1/12/2006
Type of registration
Prospectively registered
Titles & IDs
Public title
Abbreviated Course Rituximab for Auto-immune Disease Refractory to Standard Immunosuppressive Therapy
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Scientific title
Efficacy of Abbreviated Course Rituximab for Treatment of Auto-immune Disease Refractory to Standard Immunosuppressive Therapy to improve response rate and durability of response
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Auto-immune disorders
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Condition category
Condition code
Inflammatory and Immune System
1568
1568
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eligible subjects who consent to participate will receive one dose of intravenous rituximab 375mg/m2 at study entry. Response to the initial study treatment will be assessed within 2 - 8 weeks. Response assessment is disease specific, but those achieving at least a partial response will then be observed. Participants achieving minimal or no response would then receive a second intravenous dose. Patients who fail to acheive at least a partial response to two doses would come off study. Those with a partial response or better, are observed. If relapsing after at least a 3 month response, up to two further doses may be administered at two week intervals. Total duration of intervention will depend on individual response but could be from 3 to 4 years. If further doses are indicated, they will also be at 375mg/m2 I.V.
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Intervention code [1]
1470
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Treatment: Drugs
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Comparator / control treatment
No comparator.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To describe the efficacy of abbreviated course rituximab in the treatment of auto-immune disease refractory to conventional immunosuppressive therapy using the parameters of response rate.
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Assessment method [1]
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Timepoint [1]
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Disease specific autoantibodies are measured 4 weekly to week 12, 6 weekly to week 24, 12 weekly to week 96, then 6 monthly to 3 years. The schedule of testing will be altered if a second dose is administered with testing timepoints to date from the administration of the second dose.
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Primary outcome [2]
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To describe the efficacy of abbreviated course rituximab in the treatment of auto-immune disease refractory to conventional immunosuppressive therapy using the parameters of durability of response. Disease specific autoantibodies are measured 4 weekly to week 12, 6 weekly to week 24, 12 weekly to week 96, then 6 monthly to 3 years. The schedule of testing will be altered if a second dose is administered with testing timepoints to date from the administration of the second dose.
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Assessment method [2]
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Timepoint [2]
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Disease specific autoantibodies are measured 4 weekly to week 12, 6 weekly to week 24, 12 weekly to week 96, then 6 monthly to 3 years. The schedule of testing will be altered if a second dose is administered with testing timepoints to date from the administration of the second dose.
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Secondary outcome [1]
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To evaluate the effect of abbreviated rituximab doses on parameters of B cell number and function.
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Assessment method [1]
3778
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Timepoint [1]
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B cell parameters will be assessed 2 weekly to week 4, 4 weekly to week 12, 6 weekly to week 24, 12 weekly to week 96 and 6 monthly to 3 years. The schedule of testing will be altered if a second dose is administered with testing timepoints to date from the administration of the second dose.
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Eligibility
Key inclusion criteria
Auto-immune disease refractory to or intolerant of conventional immunosuppressive therapy, Informed consent.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Hepatitis B or C positivity.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/01/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Pharmaceutical industry grant
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Address [1]
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Country [1]
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Primary sponsor type
Hospital
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Name
Melbourne Health - The Royal Melbourne Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
1509
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Country [1]
1509
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Melbourne Heath
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
3167
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Ethics approval number [1]
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2006.171
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Summary
Brief summary
Rituximab's efficacy in causing profound B cell depletion when treating non hodgkin lymphoma has led to interest in its application in B cell mediated auto immune disease. Rituximab at conventional dose is expensive and not without side effects, in particular infection. There is evidence to suggest abbreviated courses may be sufficient in this scenario to achieve disease control whilst minimising potential risks of therapy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Peter Shuttleworth
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Address
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Department of Clinical Haematology/Medical Oncology
2 Centre
Royal Melbourne Hospital
C/- Post Office
Parkville VIC 3050
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Country
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Australia
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Phone
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+61 3 93428198
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Associate Professor Andrew Grigg
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Address
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Consultant Haematologist
Suite 10 & 11
Private Medical Centre
Royal Melbourne Hospital
C/- Post Office
Parkville VIC 3050
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Country
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Australia
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Phone
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+61 3 93427619
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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