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Clinical Trials/ACTRN12605000396628
ACTRN12605000396628
Recruiting
Phase 2

A Phase II study to evaluate the safety and histological response to Rituximab in adults with Sjogren's Syndrome

St Vincent's Hospital / University of New South Wales0 sites10 target enrollmentSeptember 14, 2005
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ConditionsSjogrens SyndromeInflammatory and Immune System - Autoimmune diseases

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sjogrens Syndrome
Sponsor
St Vincent's Hospital / University of New South Wales
Enrollment
10
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 14, 2005
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
St Vincent's Hospital / University of New South Wales

Eligibility Criteria

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\.

Outcomes

Primary Outcomes

Not specified

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