Interest of Mycophenolate for CIDP Weaning

NCT ID: NCT02494505

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-18
• Study Completion Date: 2018-05-09

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

mycophenolate mofetil

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

2g/day per os

placebo

placebo pills

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Mycophenolate Mofetil

2g/day per os

Intervention Type: DRUG

placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine Viala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Neurology - pitié salpetrière hospital

Paris, , France

Countries

France

Other Identifiers

P110148

Identifier Type: -

Identifier Source: org_study_id