Clinical Trial: Interest of Mycophenolate for CIDP Weaning

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)

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 Summary:

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.

Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: occurrence of a relapse during the tapering off period [ Time Frame: 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)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of withdrew patients [ Time Frame: 6 months after the withdrawal ]
  • Proportion of withdrew patients at the end of the study [ Time Frame: 24 months ]
  • Sparing treatment (composite criteria) [ Time Frame: 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 [ Time Frame: 24 months ]
  • EVA pain score [ Time Frame: 12 months ]
  • EVA pain score [ Time Frame: 24 months ]
  • ONLS scale [ Time Frame: 12 months ]
  • ONLS scale [ Time Frame: 24 months ]
  • R-ODS scale [ Time Frame: 12 months ]
  • R-ODS scale [ Time Frame: 24 months ]
  • MRC scale [ Time Frame: 12 months ]
  • MRC scale [ Time Frame: 24 months ]
  • INCAT sensory test [ Time Frame: 12 months ]
  • INCAT sensory test [ Time Frame: 24 months ]
  • 10 meters test [ Time Frame: 12 months ]
  • 10 meters test [ Time Frame: 24 months ]
  • SF-36 [ Time Frame: 12 months ]
    Quality of life scale
  • SF-36 [ Time Frame: 24 months ]
    Quality of life scale
  • Nottingham scale [ Time Frame: 12 months ]
    Quality of life scale
  • Nottingham scale [ Time Frame: 24 months ]
    Quality of life scale
  • global cost [ Time Frame: 24 months ]
    Comparison of the global cost in each group


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: June 10, 2015
Date Started: November 2013
Date Completion: November 2018
Last Updated: October 7, 2016
Last Verified: September 2016