Interest of Mycophenolate for CIDP Weaning (MYCOPID)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02494505 |
Recruitment Status :
Completed
First Posted : July 10, 2015
Last Update Posted : March 15, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Inflammatory Demyelinating Polyradiculopathy | Drug: Mycophenolate Mofetil Drug: placebo | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP) |
Actual Study Start Date : | November 18, 2013 |
Actual Primary Completion Date : | May 9, 2018 |
Actual Study Completion Date : | May 9, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: mycophenolate mofetil |
Drug: Mycophenolate Mofetil
2g/day per os |
Placebo Comparator: placebo
placebo pills
|
Drug: placebo |
- occurrence of a relapse during the tapering off period [ Time Frame: up to 18 months ]
occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period.
(the withdrawal is defined by the ability to reach the last day of IVIG treatment)
- Proportion of withdrew patients [ Time Frame: 6 months after the withdrawal ]
- Proportion of withdrew patients at the end of the study [ Time Frame: 24 months ]
- Sparing treatment (composite criteria) [ Time Frame: 24 months ]extension of the mean interval between IVIG courses at month 12 and month 24 compared to baseline, reduction of the total cumulative dose of IVIG at month 12 and month 24 in the mycophenolate group
- Time to reach the withdrawal [ Time Frame: 24 months ]
- EVA pain score [ Time Frame: 12 months ]
- EVA pain score [ Time Frame: 24 months ]
- ONLS scale [ Time Frame: 12 months ]
- ONLS scale [ Time Frame: 24 months ]
- R-ODS scale [ Time Frame: 12 months ]
- R-ODS scale [ Time Frame: 24 months ]
- MRC scale [ Time Frame: 12 months ]
- MRC scale [ Time Frame: 24 months ]
- INCAT sensory test [ Time Frame: 12 months ]
- INCAT sensory test [ Time Frame: 24 months ]
- 10 meters test [ Time Frame: 12 months ]
- 10 meters test [ Time Frame: 24 months ]
- SF-36 [ Time Frame: 12 months ]Quality of life scale
- SF-36 [ Time Frame: 24 months ]Quality of life scale
- Nottingham scale [ Time Frame: 12 months ]Quality of life scale
- Nottingham scale [ Time Frame: 24 months ]Quality of life scale
- global cost [ Time Frame: 24 months ]Comparison of the global cost in each group

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494505
France | |
Neurology - pitié salpetrière hospital | |
Paris, France, 75013 |
Principal Investigator: | Karine Viala, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02494505 |
Other Study ID Numbers: |
P110148 |
First Posted: | July 10, 2015 Key Record Dates |
Last Update Posted: | March 15, 2019 |
Last Verified: | March 2019 |
chronic inflammatory demyelinating polyradiculopathy intravenous immunoglobulin (IVIG) withdrawal |
quality of life Clinical trial cost |
Polyradiculopathy Polyradiculoneuropathy Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Mycophenolic Acid Antibiotics, Antineoplastic |
Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |