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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called rituximab (Rituxan) can help treat Sjogren's syndrome. Sjogren's syndrome is an autoimmune condition where the immune system attacks moisture-producing glands, causing severe dry eyes and dry mouth. Rituximab works by reducing a certain type of immune cell. Researchers hope it may reduce symptoms and improve saliva and tear production. You may be eligible if: - You are a female - You have been diagnosed with Sjogren's syndrome according to established European-American criteria - Your condition has been stable for at least 3 months - You are not taking aspirin or anti-inflammatory drugs (NSAIDs) within 7 days of biopsies - You are 18 years of age or older You may NOT be eligible if: - Your dry mouth was caused by radiation treatment - You have had previous salivary gland surgery - You have a blocked salivary duct - You are taking certain medications that affect saliva production - You have previously received rituximab - You have had a live vaccine within 4 weeks of treatment - You have a history of cancer, recurring infections, or immune deficiency - You are pregnant or breastfeeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12605000396628