Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000396628
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
14/09/2005
Date last updated
14/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome
Scientific title
A Phase II study to evaluate the safety and histological response to Rituximab in adults with Sjogren's Syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogrens Syndrome 501 0
Condition category
Condition code
Inflammatory and Immune System 580 580 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label, non-randomised, phase II, 48 week study of rituximab in subjects with Sjogrens Syndrome.
Intervention code [1] 382 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 673 0
To determine the safety of rituximab with Sjogrens Syndrome
Timepoint [1] 673 0
Secondary outcome [1] 1380 0
To determine the effects of rituxmab on Sjogrens Syndrome clinical severity, histological severity, functional severity, and determine the immunological effects of rituxmab in patients with Sjogrens Syndrome.
Timepoint [1] 1380 0

Eligibility
Key inclusion criteria
1. Sjogrens Syndrome according torecently updated European-American criteria, 2. Unchanged Sjogrens Syndrome for atleast 3 months 3. no aspirin or NSAID therapy within 7 days of each parotid or labial biopsy.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. radiation-induced xerostomia2. prior salivary gland surgery3. known parotid duct obstruction4. anticholinergic and sympathomimetic therapy5. prior rituxmab therapylive vaccine within 4 week of therapy6. history of cancer, recurrent bacterial infections or immunodeficiency7.pregnacy or brest feeding8. lab abnormality at screening7.

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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 631 0
Commercial sector/Industry
Name [1] 631 0
Roche Product
Country [1] 631 0
Funding source category [2] 632 0
Hospital
Name [2] 632 0
St Vincent's Hospital
Country [2] 632 0
Australia
Primary sponsor type
Name
St Vincent's Hospital / University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 517 0
Hospital
Name [1] 517 0
St Vincent's Hospital Sydney Ltd
Address [1] 517 0
Country [1] 517 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1766 0
St Vincent's Hospital Sydney
Ethics committee address [1] 1766 0
Ethics committee country [1] 1766 0
Australia
Date submitted for ethics approval [1] 1766 0
Approval date [1] 1766 0
Ethics approval number [1] 1766 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36079 0
Address 36079 0
Country 36079 0
Phone 36079 0
Fax 36079 0
Email 36079 0
Contact person for public queries
Name 9571 0
Richard Norris CNC
Address 9571 0
St Vincent's Hospital Sydney
Immunology B Ambulatory Care (IBAC)
Xavier Level 4
390 Victoria Street
Darlinghurst NSW 2010
Country 9571 0
Australia
Phone 9571 0
+61 2 83822435
Fax 9571 0
+61 2 83822090
Email 9571 0
rnorris@stvincents.com.au
Contact person for scientific queries
Name 499 0
A/Prof Andrew Carr
Address 499 0
St Vincent's Hospital Sydney
Immunology B Ambulatory Care (IBAC)
Xavier Level 4
390 Victoria Street
Darlinghurst NSW 2010
Country 499 0
Australia
Phone 499 0
+61 2 83823359
Fax 499 0
+61 2 83823489
Email 499 0
acarr@stvincents.com.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.