Rituximab Treatment in Sjogren's Syndrome
- Sponsor
- University Medical Center Groningen
- Study ID
- NCT00363350
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Sjogren's Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- rituximab (anti-CD20) — DRUG2 infusions of 1000 mg
Study Details
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.
Key Dates
- Start date
- Aug 31, 2006
- Status verified
- Feb 2009
- Primary completion
- Oct 31, 2008
- Completion
- Oct 31, 2008
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
stimulated whole salivary flow rate [ Time Frame: 48 weeks ]
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