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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000396628 |
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Date of registration:
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14/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome
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Scientific title:
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A Phase II study to evaluate the safety and histological response to Rituximab in adults with Sjogren's Syndrome |
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Date of first enrolment:
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01/06/2005 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12605000396628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety;
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Contacts
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Name:
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A/Prof Andrew Carr
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Address:
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St Vincent's Hospital Sydney
Immunology B Ambulatory Care (IBAC)
Xavier Level 4
390 Victoria Street
Darlinghurst NSW 2010
Australia |
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Telephone:
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+61 2 83823359 |
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Email:
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acarr@stvincents.com.au |
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Affiliation:
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Name:
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Richard Norris CNC
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Address:
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St Vincent's Hospital Sydney
Immunology B Ambulatory Care (IBAC)
Xavier Level 4
390 Victoria Street
Darlinghurst NSW 2010
Australia |
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Telephone:
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+61 2 83822435 |
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Email:
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rnorris@stvincents.com.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Inflammatory and Immune System - Autoimmune diseases
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Sjogrens Syndrome;
Sjogrens Syndrome
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Intervention(s)
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Open label, non-randomised, phase II, 48 week study of rituximab in subjects with Sjogrens Syndrome.
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Primary Outcome(s)
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To determine the safety of rituximab with Sjogrens Syndrome[]
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Secondary Outcome(s)
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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.[]
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Source(s) of Monetary Support
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St Vincent's Hospital
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Roche Product
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Ethics review
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Status: Not approved
Approval date:
Contact:
St Vincent's Hospital Sydney
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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