NCT01065727

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

6 years

First QC Date

February 8, 2010

Last Update Submit

November 30, 2012

Conditions

Multiple Sclerosis

Keywords

Reemitting aggressive multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • cost effectiveness

    30 years

Secondary Outcomes (1)

  • progressive neurological disability

    3 years

Study Arms (2)

mitoxantrone followed by immunomodulator

EXPERIMENTAL
Other: mitoxantrone - immunomodulator

natalizumab

ACTIVE COMPARATOR
Other: natalizumab

Interventions

mitoxantrone - immunomodulatorOTHER

mitoxantrone during 6 months and followed by immunomodulator during 2 years and half

mitoxantrone followed by immunomodulator
natalizumabOTHER

monthly natalizumab during 3 years

natalizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with remitting multiple sclerosis according to mac Donald criteria
  • aggressive remitting multiple sclerosis according to following criteria:
  • or more
  • EDSS between 2 and 5
  • aged less or equal to 40 years old for the women
  • effective contraception

You may not qualify if:

  • patients less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Cavale Blanche

Brest, 29609, France

RECRUITING

CHU Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Edan Gilles, MD PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Le Page Emmanuelle, MD

CONTACT

33-2-9928-5296emmanuelle.lepage@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2019

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

FR(2)