Interest of Mycophenolate for CIDP Weaning | NCT02494505

Studies
Interest of Mycophenolate for CIDP Weaning

NCT02494505

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

40Actual

Phase

Phase 3

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Interventions

Mycophenolate Mofetil
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2013Actual

Primary Completion Date

May 9, 2018Actual

Completion Date

May 9, 2018Actual

First Submitted Date

Jun 10, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mycophenolate mofetil	Experimental		Drug: Mycophenolate Mofetil
placebo	Placebo Comparator	placebo pills	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate Mofetil	Drug	2g/day per os	mycophenolate mofetil
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Proportion of withdrew patients		6 months after the withdrawal
Proportion of withdrew patients at the end of the study		24 months
Sparing treatment (composite criteria)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals