Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Status:
COMPLETED
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.
Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization.
Phase:
PHASE3
Details
Lead Sponsor:
Istituto Clinico Humanitas
Collaborators:
Istituto Di Ricerche Farmacologiche Mario Negri Istituto Neurologico Carlo Besta di Milano Ospedale Mondino di Pavia San Raffaele University Hospital, Italy Universita degli Studi di Genova Università di Messina Università di Napoli Federico II University of Turin, Italy