Rituximab Treatment in Sjogren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title: Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study design:

phase II trial

Study objective:

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

Number of participating centres:

1

Duration:

follow-up 48 weeks

Study medication:

2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20

Primary objective/endpoint:

stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)

Secondary objectives/endpoint:

Functional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters

Number of subjects:

30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

• NCT number: NCT00363350
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2006
• Completion date: October 2008