RecruitingPhase 2ACTRN12605000396628
A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome
A Phase II study to evaluate the safety and histological response to Rituximab in adults with Sjogren's Syndrome
Sponsor
St Vincent's Hospital / University of New South Wales
Enrollment
10 participants
Start Date
Jun 1, 2005
Study Type
Interventional
Conditions
Eligibility
Sex: FemalesMin Age: 18 Yearss
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
Open label, non-randomised, phase II, 48 week study of rituximab in subjects with Sjogrens Syndrome.
Open label, non-randomised, phase II, 48 week study of rituximab in subjects with Sjogrens Syndrome.
Locations(1)
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ACTRN12605000396628