Interest of Mycophenolate for CIDP Weaning

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)

Conditions
-----------------
Chronic Inflammatory Demyelinating Polyradiculopathy

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mycophenolate mofetil<br> | Drug: Mycophenolate Mofetil<br>* 2g/day per os<br>|
| Placebo Comparator: placebo<br>placebo pills | Drug: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of withdrew patients |  | 6 months after the withdrawal | 
| Proportion of withdrew patients at the end of the study |  | 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 | 24 months | 
| Time to reach the withdrawal |  | 24 months | 
| EVA pain score |  | 12 months | 
| EVA pain score |  | 24 months | 
| ONLS scale |  | 12 months | 
| ONLS scale |  | 24 months | 
| R-ODS scale |  | 12 months | 
| R-ODS scale |  | 24 months | 
| MRC scale |  | 12 months | 
| MRC scale |  | 24 months | 
| INCAT sensory test |  | 12 months | 
| INCAT sensory test |  | 24 months | 
| 10 meters test |  | 12 months | 
| 10 meters test |  | 24 months | 
| SF-36 | Quality of life scale | 12 months | 
| SF-36 | Quality of life scale | 24 months | 
| Nottingham scale | Quality of life scale | 12 months | 
| Nottingham scale | Quality of life scale | 24 months | 
| global cost | Comparison of the global cost in each group | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cost, chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial