Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02494505
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.
Study:
NCT02494505
Study Brief:
Protocol Section:
NCT02494505