Interest of Mycophenolate for CIDP Weaning (MYCOPID)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Treatments

Drug: Mycophenolate Mofetil

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02494505

P110148

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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