Monitoring of Patients Followed for a Multiple Sclerosis... | NCT02901106

Studies
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate

NCT02901106

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Jan 9, 2019Actual

Enrollment

11Actual

Phase

Phase 4

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Dimethyl fumarate

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Another surveillance protocol was initiated by the OFSEP (OFSEP cohort) which allows to follow all the patients, whatever their treatment.

Expanded Access Info

Start Date

May 23, 2017Actual

Primary Completion Date

Oct 17, 2017Actual

Completion Date

Oct 17, 2017Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 15, 2016Estimated

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

Jan 7, 2019

Last Update Posted Date

Jan 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with recurring-remitting MS	Experimental		Drug: Dimethyl fumarate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dimethyl fumarate	Drug	Patient follow-up at 6, 12, 18, 36, and 60 months after the start of Dimethyl fumarate Systematization of cerebral MRI examination at 18 month and 5 years from the beginning of treatment by Dimethyl fumarate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with a relapse and/or progressive worsening of disease (EDSS score)		After one year of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient 18 years old and more
with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP)
for which treatment with dimethyl-fumarate has been prescribed
followed at the Rothschild Foundation in the Neurology Department
having given written consent to participation in the study

Exclusion Criteria:

pregnant or breastfeeding woman
patient with a measure of legal protection
subject unaffiliated insurance

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmique Adolphe de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069462	Dimethyl Fumarate

Ancestor Terms

ID	Term
D005650	Fumarates
D003998	Dicarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided