Interest of Mycophenolate for CIDP Weaning (MYCOPID)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyradiculopathy
• Intervention / Treatment: Drug: placebo; Drug: Mycophenolate Mofetil

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Neurology - pitié salpetrière hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mycophenolate mofetil	Drug: Mycophenolate Mofetil; 2g/day per os
Placebo Comparator: placebo; placebo pills	Drug: placebo

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Karine Viala, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2013
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): May 9, 2018

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; Clinical trial; withdrawal; cost; chronic inflammatory demyelinating polyradiculopathy; intravenous immunoglobulin (IVIG)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Polyradiculopathy; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: P110148