Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02494505
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02494505
Study Brief:
Protocol Section:
NCT02494505