Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-01 @ 7:25 AM
Study NCT ID:
NCT00363350
Status:
COMPLETED
Last Update Posted:
2009-02-24
First Post:
2006-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab Treatment in Sjogren's Syndrome
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Rituximab for the Treatment of Primary Sjögren's 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 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)
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: