A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome
Phase 2
Recruiting
- Conditions
- Sjogrens SyndromeInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12605000396628
- Lead Sponsor
- St Vincent's Hospital / University of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety of rituximab with Sjogrens Syndrome[]
- Secondary Outcome Measures
Name Time Method 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.[]