Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT00363350
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)
Study:
NCT00363350
Study Brief:
Protocol Section:
NCT00363350