Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 11:27 PM
Study NCT ID:
NCT02494505
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Mycophenolate for CIDP Weaning
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYCOPID
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: