Interest of Mycophenolate for CIDP Weaning

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Brief Title

Interest of Mycophenolate for CIDP Weaning

Official Title

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

occurrence of a relapse during the tapering off period

Secondary Outcome

 Proportion of withdrew patients

Condition

Chronic Inflammatory Demyelinating Polyradiculopathy

Intervention

Mycophenolate Mofetil

Study Arms / Comparison Groups

 mycophenolate mofetil
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

November 18, 2013

Completion Date

May 9, 2018

Primary Completion Date

May 9, 2018

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karine Viala, MD, PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02494505

Organization ID

P110148


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Karine Viala, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

March 2019