Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Sponsor
Istituto Clinico Humanitas
Study ID
NCT06325943
Phase
PHASE3
Status
Completed

Conditions

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2019
Status verified
Mar 2024
Primary completion
May 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment arm
    Rituximab Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6
  • Placebo Comparator: Placebo arm
    Placebo Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6

Primary Outcome Measure

Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability [ Time Frame: 6 months ]

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