Viewing Study NCT00363350



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Study NCT ID: NCT00363350
Status: COMPLETED
Last Update Posted: 2009-02-24
First Post: 2006-08-10

Brief Title: Rituximab Treatment in Sjogrens Syndrome
Sponsor: University Medical Center Groningen
Organization: University Medical Center Groningen

Study Overview

Official Title: Rituximab for the Treatment of Primary Sjögrens Syndrome a Double Blinded Randomized Placebo-Controlled Trial
Status: COMPLETED
Status Verified Date: 2009-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 objectiveendpoint

stimulated salivary gland function stimulated submandibularsublingual and parotid saliva

Secondary objectivesendpoint

Functional parameters Laboratory parameters Subjective parameters HistologicalMolecular parameters

Number of subjects

30 patients with primary SS 20 patients rituximab treatment 10 patients placebo

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None