Interest of Mycophenolate for CIDP Weaning

• Status: Completed
• Trial end date: 2018-05-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

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