Interest of Mycophenolate for CIDP Weaning

Assistance Publique - Hôpitaux de Paris40 enrolled

Overview

The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.

The secondary objectives are : * Study if the mycophenolate could improve the proportion of withdrew patients. * Study if the mycophenolate could improve the reduction of IVIG dose or could prolong the interval between two courses of IVIG compared to the baseline interval at month 12 and month 24 (= sparing treatment criteria). * Study if mycophenolate could short the delay to perform the IVIG withdrawal. * Study if mycophenolate could improve the clinical scores (ONLS, R-ODS MRC, INCAT sensory, 10 meters test) or pain score at month 12 and month 24. * Study if mycophenolate could improve the quality of life at month12 and month 24. * Identify clinical, biological and electrophysiological factors associated with withdrawal. * To assess the pharmacokinetics factors (Area under the curve measuring the exposure to mycophenolate) and the pharmacogenetic factors (cytochrome and carrier, FcgammaR) associated with withdrawal. * Evaluate the tolerance of Mycophenolate in this new indication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Interventions

Mycophenolate MofetilDRUG

2g/day per os

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria : * Patient older than eighteen * Written informed consent for study participation * Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria) * Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period) * Having received at least 3 courses of IVIG * Negative pregnancy test for women of child-bearing age Exclusion criteria : * No social security benefit * Pregnancy or intention to become pregnant * Nursing mother * Recent or active VIH or hepatitis B or C , or lyme infections * Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome * Neutropenia \< 1G/L * Malignancy during the 10 years before the inclusion * Patients having received Mycophenolate * History of allergy to mycophenolate or placebo excipient * Patients having received immunosuppressive drugs during the 3 months period before the inclusion * Patients receiving : plasma exchange, magnesium hydroxide, aluminium hydroxide, cholestyramine

Locations (1)

Neurology - pitié salpetrière hospital

Paris, France

Outcomes

Primary Outcomes

occurrence of a relapse during the tapering off period

occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period. (the withdrawal is defined by the ability to reach the last day of IVIG treatment)

Time frame: up to 18 months

Secondary Outcomes

Proportion of withdrew patients

Time frame: 6 months after the withdrawal

Proportion of withdrew patients at the end of the study

Time frame: 24 months

Sparing treatment (composite criteria)

extension of the mean interval between IVIG courses at month 12 and month 24 compared to baseline, reduction of the total cumulative dose of IVIG at month 12 and month 24 in the mycophenolate group

Time frame: 24 months

Time to reach the withdrawal

Time frame: 24 months

EVA pain score

Time frame: 12 months

EVA pain score

Time frame: 24 months

ONLS scale

Time frame: 12 months

ONLS scale

Time frame: 24 months

R-ODS scale

Time frame: 12 months

R-ODS scale

Data from ClinicalTrials.gov

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