Interest of Mycophenolate for CIDP Weaning

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02494505
• Date of registration: 10/06/2015
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Interest of Mycophenolate for CIDP Weaning MYCOPID
• Scientific title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
• Date of first enrolment: November 18, 2013
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02494505
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Karine Viala, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculopathy

Intervention(s)

Drug: placebo

Drug: Mycophenolate Mofetil

Primary Outcome(s)

occurrence of a relapse during the tapering off period [Time Frame: up to 18 months]

Secondary Outcome(s)

global cost [Time Frame: 24 months]

Nottingham scale [Time Frame: 24 months]

Proportion of withdrew patients at the end of the study [Time Frame: 24 months]

R-ODS scale [Time Frame: 12 months]

10 meters test [Time Frame: 24 months]

EVA pain score [Time Frame: 24 months]

INCAT sensory test [Time Frame: 12 months]

ONLS scale [Time Frame: 24 months]

EVA pain score [Time Frame: 12 months]

INCAT sensory test [Time Frame: 24 months]

Nottingham scale [Time Frame: 12 months]

R-ODS scale [Time Frame: 24 months]

ONLS scale [Time Frame: 12 months]

Proportion of withdrew patients [Time Frame: 6 months after the withdrawal]

MRC scale [Time Frame: 12 months]

SF-36 [Time Frame: 24 months]

Time to reach the withdrawal [Time Frame: 24 months]

10 meters test [Time Frame: 12 months]

Sparing treatment (composite criteria) [Time Frame: 24 months]

MRC scale [Time Frame: 24 months]

SF-36 [Time Frame: 12 months]

Secondary ID(s)

P110148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors