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.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12605000396628