Chronic Inflammatory Demyelinating Polyradiculopathy
Conditions
Keywords
chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial, cost
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.
Interventions
DRUGMycophenolate Mofetil
2g/day per os
DRUGplacebo
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| ONLS scale | 12 months | — |
| R-ODS scale | 12 months | — |
| Proportion of withdrew patients | 6 months after the withdrawal | — |
| INCAT sensory test | 12 months | — |
| 10 meters test | 12 months | — |
| SF-36 | 12 months | Quality of life scale |
| Nottingham scale | 12 months | Quality of life scale |
| global cost | 24 months | Comparison of the global cost in each group |
| MRC scale | 12 months | — |
Countries
France
Outcome results
None listed