Clinical trial NCT02494505: Interest of Mycophenolate for CIDP Weaning
Official title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Inflammatory Demyelinating Polyradiculopathy
Keywords: chronic inflammatory demyelinating polyradiculopathy
intravenous immunoglobulin (IVIG)
withdrawal
quality of life
Clinical trial
cost
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: occurrence of a relapse during the tapering off period
timeFrame: up to 18 months
Secondary outcomes:
measure: Proportion of withdrew patients
timeFrame: 6 months after the withdrawal
measure: Proportion of withdrew patients at the end of the study
timeFrame: 24 months
measure: Sparing treatment (composite criteria)
timeFrame: 24 months
measure: Time to reach the withdrawal
timeFrame: 24 months
measure: EVA pain score
timeFrame: 12 months
measure: EVA pain score
timeFrame: 24 months
measure: ONLS scale
timeFrame: 12 months
measure: ONLS scale
timeFrame: 24 months
measure: R-ODS scale
timeFrame: 12 months
measure: R-ODS scale
timeFrame: 24 months
measure: MRC scale
timeFrame: 12 months
measure: MRC scale
timeFrame: 24 months
measure: INCAT sensory test
timeFrame: 12 months
measure: INCAT sensory test
timeFrame: 24 months
measure: 10 meters test
timeFrame: 12 months
measure: 10 meters test
timeFrame: 24 months
measure: SF-36
timeFrame: 12 months
measure: SF-36
timeFrame: 24 months
measure: Nottingham scale
timeFrame: 12 months
measure: Nottingham scale
timeFrame: 24 months
measure: global cost
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Neurology - pitié salpetrière hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karine Viala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: