Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interest of Mycophenolate for CIDP Weaning (MYCOPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494505
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 10, 2015
First Posted Date  ICMJE July 10, 2015
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE November 18, 2013
Actual Primary Completion Date May 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of Mycophenolate for CIDP Weaning
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammatory Demyelinating Polyradiculopathy
Intervention  ICMJE
  • Drug: Mycophenolate Mofetil
    2g/day per os
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: mycophenolate mofetil
    Intervention: Drug: Mycophenolate Mofetil
  • Placebo Comparator: placebo
    placebo pills
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
78
Actual Study Completion Date  ICMJE May 9, 2018
Actual Primary Completion Date May 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Patient older than eighteen
  • Written informed consent for study participation
  • Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria)
  • Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period)
  • Having received at least 3 courses of IVIG
  • Negative pregnancy test for women of child-bearing age

Exclusion criteria :

  • No social security benefit
  • Pregnancy or intention to become pregnant
  • Nursing mother
  • Recent or active VIH or hepatitis B or C , or lyme infections
  • Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome
  • Neutropenia < 1G/L
  • Malignancy during the 10 years before the inclusion
  • Patients having received Mycophenolate
  • History of allergy to mycophenolate or placebo excipient
  • Patients having received immunosuppressive drugs during the 3 months period before the inclusion
  • Patients receiving : plasma exchange, magnesium hydroxide, aluminium hydroxide, cholestyramine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02494505
Other Study ID Numbers  ICMJE P110148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karine Viala, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP