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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02494505
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 3
Start date November 18, 2013
Completion date May 9, 2018