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)
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.