Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
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
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