protocolSection identificationModule nctId: NCT06325943, orgStudyIdInfo id: CIDPRIT, briefTitle: Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, acronym: CIDPRIT, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, collaborators name: Ospedale Mondino di Pavia, collaborators name: University of Turin, Italy, collaborators name: Istituto Neurologico Carlo Besta di Milano, collaborators name: San Raffaele University Hospital, Italy, collaborators name: Università di Messina, collaborators name: Universita degli Studi di Genova, collaborators name: Istituto Di Ricerche Farmacologiche Mario Negri, collaborators name: Università di Napoli Federico II, descriptionModule briefSummary: 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., conditionsModule conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Rituximab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability, primaryOutcomes measure: Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability, primaryOutcomes measure: Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability, secondaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale,, range 0-10 points with higher values meaning more severe disability, secondaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability, secondaryOutcomes measure: treatment suspension, secondaryOutcomes measure: time to worsening, secondaryOutcomes measure: Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state, otherOutcomes measure: motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment, otherOutcomes measure: clinical form, otherOutcomes measure: response to rituximab in patients with antinerve antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico Humanitas, city: Rozzano, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False