Status:
COMPLETED
Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Primary Sjögren's Syndrome
Xerostomia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The primary purpose of the study is to determine whether B-cell depletion with Rituximab has an effect on the oral, ocular and general disease manifestations in patients with primary Sjögren´s syndrom...
Detailed Description
The trial is designed as a double-blind parallel comparison between 2 infusions of 1 g Rituximab and solvent (saline) given two weeks apart, in 22 patients with the diagnosis of primary Sjögren's synd...
Eligibility Criteria
Inclusion
- Female patients fulfilling the current American-European consensus classification criteria.
- Fertile-age female patients must use safe anticonceptional methods such as pills, mini-pills, or intrauterine spiral.
- The fertile-age females included in the study must not get pregnant in at least 12 months after the last treatment with Rituximab.
Exclusion
- Pregnancy and lactation.
- Fertile-age females who do not use safe anticonceptional methods.
- Patients in systemic treatment with cytostatics.
- Patients who previously have been treated with Rituximab.
- Patient with an active infection that requires antibiotic treatment.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00426543
Start Date
January 1 2007
End Date
August 1 2010
Last Update
March 14 2017
Active Locations (1)
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1
Institute of Odontology, Faculty of Health Sciences, University of Copenhagen
Copenhagen, Denmark, 2200