Trial Review

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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Auto-immune disorders 1472 0
Condition category
Condition code
Inflammatory and Immune System 1568 1568 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1470 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2163 0
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.
Timepoint [1] 2163 0
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.
Primary outcome [2] 2164 0
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.
Timepoint [2] 2164 0
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.
Secondary outcome [1] 3778 0
To evaluate the effect of abbreviated rituximab doses on parameters of B cell number and function.
Timepoint [1] 3778 0
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.

Eligibility
Key inclusion criteria
Auto-immune disease refractory to or intolerant of conventional immunosuppressive therapy, Informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hepatitis B or C positivity.

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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1710 0
Commercial sector/Industry
Name [1] 1710 0
Pharmaceutical industry grant
Country [1] 1710 0
Primary sponsor type
Hospital
Name
Melbourne Health - The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 1509 0
None
Name [1] 1509 0
none
Address [1] 1509 0
Country [1] 1509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3167 0
Melbourne Heath
Ethics committee address [1] 3167 0
Ethics committee country [1] 3167 0
Australia
Date submitted for ethics approval [1] 3167 0
Approval date [1] 3167 0
Ethics approval number [1] 3167 0
2006.171

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27404 0
Address 27404 0
Country 27404 0
Phone 27404 0
Fax 27404 0
Email 27404 0
Contact person for public queries
Name 10659 0
Peter Shuttleworth
Address 10659 0
Department of Clinical Haematology/Medical Oncology
2 Centre
Royal Melbourne Hospital
C/- Post Office
Parkville VIC 3050
Country 10659 0
Australia
Phone 10659 0
+61 3 93428198
Fax 10659 0
Email 10659 0
peter.shuttleworth@mh.org.au
Contact person for scientific queries
Name 1587 0
Associate Professor Andrew Grigg
Address 1587 0
Consultant Haematologist
Suite 10 & 11
Private Medical Centre
Royal Melbourne Hospital
C/- Post Office
Parkville VIC 3050
Country 1587 0
Australia
Phone 1587 0
+61 3 93427619
Fax 1587 0
Email 1587 0
andrew.grigg@mh.org.au

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.