Overview

This trial is active, not recruiting.

Condition chronic inflammatory demyelinating polyradiculopathy
Treatments mycophenolate mofetil, placebo
Phase phase 3
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2013
End date November 2017
Trial size 40 participants
Trial identifier NCT02494505, P110148

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
mycophenolate mofetil
2g/day per os
(Placebo Comparator)
placebo pills
placebo

Primary Outcomes

Measure
occurrence of a relapse during the tapering off period
time frame: up to 18 months

Secondary Outcomes

Measure
Proportion of withdrew patients
time frame: 6 months after the withdrawal
Proportion of withdrew patients at the end of the study
time frame: 24 months
Sparing treatment (composite criteria)
time frame: 24 months
Time to reach the withdrawal
time frame: 24 months
EVA pain score
time frame: 12 months
EVA pain score
time frame: 24 months
ONLS scale
time frame: 12 months
ONLS scale
time frame: 24 months
R-ODS scale
time frame: 12 months
R-ODS scale
time frame: 24 months
MRC scale
time frame: 12 months
MRC scale
time frame: 24 months
INCAT sensory test
time frame: 12 months
INCAT sensory test
time frame: 24 months
10 meters test
time frame: 12 months
10 meters test
time frame: 24 months
SF-36
time frame: 12 months
SF-36
time frame: 24 months
Nottingham scale
time frame: 12 months
Nottingham scale
time frame: 24 months
global cost
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
Principal investigator Karine Viala, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.