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Interest of Mycophenolate for CIDP Weaning (MYCOPID)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Demyelinating Polyradiculopathy Drug: Mycophenolate Mofetil Drug: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
Actual Study Start Date : November 18, 2013
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : May 9, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: mycophenolate mofetil Drug: Mycophenolate Mofetil
2g/day per os
Placebo Comparator: placebo
placebo pills
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494505


Locations
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France
Neurology - pitié salpetrière hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Karine Viala, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02494505    
Other Study ID Numbers: P110148
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
chronic inflammatory demyelinating polyradiculopathy
intravenous immunoglobulin (IVIG)
withdrawal
 quality of life
Clinical trial
cost
Additional relevant MeSH terms:
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Polyradiculopathy
Polyradiculoneuropathy
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
 Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action