MYCOPID: Interest of Mycophenolate for CIDP Weaning

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02494505

Collaborator

(none)

Enrollment

Location

Arms

53.7

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyradiculopathy	Drug: Mycophenolate Mofetil Drug: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2013

Actual Primary Completion Date :

May 9, 2018

Actual Study Completion Date :

May 9, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: mycophenolate mofetil

Drug: Mycophenolate Mofetil

2g/day per os

Placebo Comparator: placebo

placebo pills

Drug: placebo

Outcome Measures

Primary Outcome Measures

occurrence of a relapse during the tapering off period [up to 18 months]
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)

Secondary Outcome Measures

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) [24 months]
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 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 [12 months]
Quality of life scale
SF-36 [24 months]
Quality of life scale
Nottingham scale [12 months]
Quality of life scale
Nottingham scale [24 months]
Quality of life scale
global cost [24 months]
Comparison of the global cost in each group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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