NCT06325943

Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

An Italian Database-based Randomized Controlled Trial With Rituximab in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Type	Name	Description
DRUG	Rituximab	Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
OTHER	Placebo	Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-05-30
• Completion: 2023-11-30
• First posted: 2024-03-22
• Last updated: 2024-03-26

Locations

1 site across 1 country: Italy