Impact Study of 2 Therapeutic Strategy for Aggressive Rem... | NCT01065727

Studies
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

NCT01065727

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 15, 2026Actual

Enrollment

144Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

mitoxantrone - immunomodulator
natalizumab

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

Jun 2026

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

Mar 2010Actual

Primary Completion Date

Nov 8, 2022Actual

Completion Date

Nov 2023Actual

First Submitted Date

Feb 8, 2010

First Submission Date that Met QC Criteria

Feb 8, 2010

First Posted Date

Feb 9, 2010Estimated

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

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mitoxantrone followed by immunomodulator	Experimental		Other: mitoxantrone - immunomodulator
natalizumab	Active Comparator		Other: natalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitoxantrone - immunomodulator	Other	mitoxantrone during 6 months and followed by immunomodulator during 2 years and half	mitoxantrone followed by immunomodulator

Measure	Description	Time Frame
cost effectiveness		30 years

Measure	Description	Time Frame
progressive neurological disability		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with remitting multiple sclerosis according to mac Donald criteria
aggressive remitting multiple sclerosis according to following criteria:
2 or less disabling relapse during the 12 months before inclusion
1 or more
EDSS between 2 and 5
aged less or equal to 40 years old for the women
effective contraception

Exclusion Criteria:

patients less than 18 years old

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

Name	Affiliation	Role
Edan Gilles, MD PhD	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Cavale Blanche		Brest		29609	France
CHU Rennes

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069442	Natalizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided