Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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 syndrome, that is, an effect on the symptoms of oral and ocular dryness, improvement of the glandular function and a beneficial effect on the general symptoms such as fatigue. The secondary purpose of the study is the investigate the underlying autoimmune and pathophysiological mechanisms in Sjögren´s syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Copenhagen
• Collaborator: Rigshospitalet, Denmark
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.