Interest of Mycophenolate for CIDP Weaning
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculopathy
- Interventions
- Drug: placebo
- Registration Number
- NCT02494505
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo pills mycophenolate mofetil Mycophenolate Mofetil -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Proportion of withdrew patients 6 months after the withdrawal Time to reach the withdrawal 24 months 10 meters test 24 months 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
ONLS scale 24 months MRC scale 24 months INCAT sensory test 24 months SF-36 24 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
EVA pain score 24 months R-ODS scale 24 months
Trial Locations
- Locations (1)
Neurology - pitié salpetrière hospital
🇫🇷Paris, France