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CompletedNCT02494505MYCOPIDUpdated Mar 15, 2019

Interest of Mycophenolate for CIDP Weaning

A Phase 3 interventional study of Mycophenolate Mofetil and placebo in Chronic Inflammatory Demyelinating Polyradiculopathy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Nov 2013, registered Jun 2015).
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyradiculopathy

Keywords

  • chronic inflammatory demyelinating polyradiculopathy
  • intravenous immunoglobulin (IVIG)
  • withdrawal
  • quality of life
  • Clinical trial
  • cost
03

In context

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    mycophenolate mofetil

    Drug: Mycophenolate Mofetil

  • Placebo comparator
    placebo

    placebo pills

    Drug: placebo

Interventions

  • DrugMycophenolate Mofetil

    2g/day per os

  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: up to 18 months

Secondary outcomes

  1. Proportion of withdrew patients

    Time frame: 6 months after the withdrawal

  2. Proportion of withdrew patients at the end of the study

    Time frame: 24 months

  3. 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 frame: 24 months

  4. Time to reach the withdrawal

    Time frame: 24 months

  5. EVA pain score

    Time frame: 12 months

  6. EVA pain score

    Time frame: 24 months

  7. ONLS scale

    Time frame: 12 months

  8. ONLS scale

    Time frame: 24 months

  9. R-ODS scale

    Time frame: 12 months

  10. R-ODS scale

    Time frame: 24 months

  11. MRC scale

    Time frame: 12 months

  12. MRC scale

    Time frame: 24 months

  13. INCAT sensory test

    Time frame: 12 months

  14. INCAT sensory test

    Time frame: 24 months

  15. 10 meters test

    Time frame: 12 months

  16. 10 meters test

    Time frame: 24 months

  17. SF-36

    Quality of life scale

    Time frame: 12 months

  18. SF-36

    Quality of life scale

    Time frame: 24 months

  19. Nottingham scale

    Quality of life scale

    Time frame: 12 months

  20. Nottingham scale

    Quality of life scale

    Time frame: 24 months

  21. global cost

    Comparison of the global cost in each group

    Time frame: 24 months

07

Study locations

1 site
  • Neurology - pitié salpetrière hospital
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02494505
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 10, 2015
Start date
Nov 18, 2013
Primary completion
May 9, 2018
Completion
May 9, 2018
Last update
Mar 15, 2019

Study contacts

Karine Viala, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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