NCT00219908

Brief Summary

The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_2

Geographic Reach
2 countries

23 active sites

Status
terminated

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

July 1, 1999

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 22, 2005

Status Verified

September 1, 2005

First QC Date

September 16, 2005

Last Update Submit

December 21, 2005

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple sclerosisMitoxantroneMethylprednisoloneInterferon beta1bRelapseMRIEDSS

Outcome Measures

Primary Outcomes (1)

  • Time to confirmed progression of at least one EDSS point during the 3 years of the study.

Secondary Outcomes (5)

  • - percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study,

  • - annual rate of relapse;

  • - percentage of relapse-free patients during the study period,

  • - quality of life,

  • - percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden).

Interventions

MitoxantroneDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age : 18-45 years,
  • Clinical disease satisfying the Poser criteria (Amdmt n°4)
  • relapsing-remitting disease (Amdmt N°4)
  • at least 2 exacerbations within the preceding 12 months, having left sequelae,
  • written informed consent

You may not qualify if:

  • pregnancy and breast-feeding
  • use of an insufficiency effective contraceptive method,
  • general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
  • treatment with azathioprine during the 3 months preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Hôpital Cote de Nacre

Caen, 14033, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU Henri Mondor

Créteil, 94000, France

Location

Hôpital Général

Dijon, 21033, France

Location

CHU Limoges

Limoges, 87042, France

Location

Institut Catholique de Lille

Lomme, 59462, France

Location

Pierre Weitheimer Hospital

Lyon, 69394, France

Location

Chu Timone

Marseille, 13385, France

Location

Centre Guy de Chauliac

Montpellier, 34295, France

Location

CHU Hôpital Central

Nancy, 54035, France

Location

CHU

Nice, 06000, France

Location

CHU Pitié-Salpétrière

Paris, 75013, France

Location

Hôpital Saint-Anne

Paris, 75014, France

Location

Centre Fondation Rotschild

Paris, 75019, France

Location

Tenon Hospital

Paris, 759170, France

Location

CHU Strasbourg

Strasbourg, 67000, France

Location

CHU Purpan

Toulouse, 31059, France

Location

Psichiatriche dell'Università di Bari, Policlinico

Bari, 70122, Italy

Location

Dipartimento di Scienze Neurologiche e Psichiatriche

Florence, 50134, Italy

Location

Hospedal Civile

Gallarate, 21013, Italy

Location

Neuroriabilitazione dell'Università

Genova, 16132, Italy

Location

Fondazionz SAN Raffaele del monte tabor

Milan, 20132, Italy

Location

Clinica Neurologica Università di Torino

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisRecurrence

Interventions

Mitoxantrone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Gilles EDAN, Professor

    CHU Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

July 1, 1999

Study Completion

June 1, 2006

Last Updated

December 22, 2005

Record last verified: 2005-09

Locations

IT(6)FR(17)