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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
proportion of patients with CIDP who worsen by at least one point in the INCAT score within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability
proportion of patients with CIDP who worsen by at least two points in the MRC sum score within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability
proportion of patients with CIDP who worsen by at least four points in the I-RODS scale within six months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, , range 0-10 points with higher values meaning more severe disability
improvement of disability (INCAT score) compared to placebo after 6, 12 and 18 months from the start of treatment
Time frame: 6,12,18 months
Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability
efficacy of rituximab compared to placebo in reducing the number of patients with CIDP who worsen by at least one point in the INCAT score within 12 months after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 12 months
treatment suspension
proportion of patients who suspend the treatment with rituximab or placebo for adverse events or for voluntary reasons or who develop adverse events in the 12 months following the start of treatment.
Time frame: 12 months
time to worsening
to compare the mean time for patients with CIDP treated with rituximab or placebo to worsen by at least one point in the INCAT score after suspension of six-month treatment with intravenous or subcutaneous immunoglobulin
Time frame: 6 months
Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state
to determine whether the association of rituximab to intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) in patients with CIDP may improve compared to placebo the quality of life of the patients determined by SF-36 after 6, 12 and 18 months from the start of treatment.
Time frame: 6,12,18 months
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