Interest of Mycophenolate for CIDP Weaning (NCT02494505) | Clinical Trial Compass
CompletedPhase 3
Interest of Mycophenolate for CIDP Weaning
France40 participantsStarted 2013-11-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
occurrence of a relapse during the tapering off period