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Interest of Mycophenolate for CIDP Weaning (MYCOPID)

Primary Purpose

Chronic Inflammatory Demyelinating Polyradiculopathy

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mycophenolate Mofetil
placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculopathy focused on measuring chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial, cost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurology - pitié salpetrière hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mycophenolate mofetil

placebo

Arm Description

placebo pills

Outcomes

Primary Outcome Measures

occurrence of a relapse during the tapering off period
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)

Secondary Outcome Measures

Proportion of withdrew patients
Proportion of withdrew patients at the end of the study
Sparing treatment (composite criteria)
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
EVA pain score
EVA pain score
ONLS scale
ONLS scale
R-ODS scale
R-ODS scale
MRC scale
MRC scale
INCAT sensory test
INCAT sensory test
10 meters test
10 meters test
SF-36
Quality of life scale
SF-36
Quality of life scale
Nottingham scale
Quality of life scale
Nottingham scale
Quality of life scale
global cost
Comparison of the global cost in each group

Full Information

First Posted
June 10, 2015
Last Updated
March 14, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02494505
Brief Title
Interest of Mycophenolate for CIDP Weaning
Acronym
MYCOPID
Official Title
Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 18, 2013 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculopathy
Keywords
chronic inflammatory demyelinating polyradiculopathy, intravenous immunoglobulin (IVIG), withdrawal, quality of life, Clinical trial, cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mycophenolate mofetil
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo pills
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
2g/day per os
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
occurrence of a relapse during the tapering off period
Description
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)
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Proportion of withdrew patients
Time Frame
6 months after the withdrawal
Title
Proportion of withdrew patients at the end of the study
Time Frame
24 months
Title
Sparing treatment (composite criteria)
Description
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 Frame
24 months
Title
Time to reach the withdrawal
Time Frame
24 months
Title
EVA pain score
Time Frame
12 months
Title
EVA pain score
Time Frame
24 months
Title
ONLS scale
Time Frame
12 months
Title
ONLS scale
Time Frame
24 months
Title
R-ODS scale
Time Frame
12 months
Title
R-ODS scale
Time Frame
24 months
Title
MRC scale
Time Frame
12 months
Title
MRC scale
Time Frame
24 months
Title
INCAT sensory test
Time Frame
12 months
Title
INCAT sensory test
Time Frame
24 months
Title
10 meters test
Time Frame
12 months
Title
10 meters test
Time Frame
24 months
Title
SF-36
Description
Quality of life scale
Time Frame
12 months
Title
SF-36
Description
Quality of life scale
Time Frame
24 months
Title
Nottingham scale
Description
Quality of life scale
Time Frame
12 months
Title
Nottingham scale
Description
Quality of life scale
Time Frame
24 months
Title
global cost
Description
Comparison of the global cost in each group
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine Viala, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology - pitié salpetrière hospital
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Interest of Mycophenolate for CIDP Weaning

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