Chronic Inflammatory Demyelinating Polyradiculopathy Clinical Trial
— MYCOPIDOfficial title:
Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)
| Verified date | March 2019 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 9, 2018 |
| Est. primary completion date | May 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Neurology - pitié salpetrière hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | occurrence of a relapse during the tapering off period | 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) |
up to 18 months | |
| Secondary | Proportion of withdrew patients | 6 months after the withdrawal | ||
| Secondary | Proportion of withdrew patients at the end of the study | 24 months | ||
| Secondary | Sparing treatment (composite criteria) | 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 | 24 months | |
| Secondary | Time to reach the withdrawal | 24 months | ||
| Secondary | EVA pain score | 12 months | ||
| Secondary | EVA pain score | 24 months | ||
| Secondary | ONLS scale | 12 months | ||
| Secondary | ONLS scale | 24 months | ||
| Secondary | R-ODS scale | 12 months | ||
| Secondary | R-ODS scale | 24 months | ||
| Secondary | MRC scale | 12 months | ||
| Secondary | MRC scale | 24 months | ||
| Secondary | INCAT sensory test | 12 months | ||
| Secondary | INCAT sensory test | 24 months | ||
| Secondary | 10 meters test | 12 months | ||
| Secondary | 10 meters test | 24 months | ||
| Secondary | SF-36 | Quality of life scale | 12 months | |
| Secondary | SF-36 | Quality of life scale | 24 months | |
| Secondary | Nottingham scale | Quality of life scale | 12 months | |
| Secondary | Nottingham scale | Quality of life scale | 24 months | |
| Secondary | global cost | Comparison of the global cost in each group | 24 months |