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Completed

NCT Number: NCT02494505

Interest of Mycophenolate for CIDP Weaning

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.

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Key information

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Neurology - pitié salpetrière hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate mofetil

Drug

2g/day per os

Placebo

Drug

Primary outcomes

  1. 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)

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)

    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

  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

    Time frame: 12 months

    Quality of life scale

  18. SF-36

    Time frame: 24 months

    Quality of life scale

  19. Nottingham scale

    Time frame: 12 months

    Quality of life scale

  20. Nottingham scale

    Time frame: 24 months

    Quality of life scale

  21. global cost

    Time frame: 24 months

    Comparison of the global cost in each group

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MYCOPID

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2015
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.