Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis

This study has been terminated.

First Received: September 16, 2005 Last Updated: December 21, 2005 History of Changes

Sponsors and Collaborators:	Rennes University Hospital Bayer Wyeth Farmades, Italy
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00219908

Purpose

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.

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Mitoxantrone	Phase II

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride Interferon beta Interferon-beta Interferon beta-1b Interferons

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

- 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).

Estimated Enrollment:	124
Study Start Date:	July 1999
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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,
MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
written informed consent

Exclusion Criteria:

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
clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219908

Locations

France
CHU Purpan
Toulouse, France, 31059
Pierre Weitheimer Hospital
Lyon, France, 69394
CHU Pitié-Salpétrière
Paris, France, 75013
Tenon Hospital
Paris, France, 759170
CHU Henri Mondor
Creteil, France, 94000
CHU Strasbourg
Strasbourg, France, 67000
CHU Hôpital Central
Nancy, France, 54035
Hôpital Cote de Nacre
Caen, France, 14033
Institut Catholique de Lille
Lomme, France, 59462
Centre Fondation Rotschild
Paris, France, 75019
CHU TIMONE
Marseille, France, 13385
CHU Limoges
Limoges, France, 87042
Hôpital Saint-Anne
Paris, France, 75014
Centre Guy de Chauliac
Montpellier, France, 34295
Hôpital Général
Dijon, France, 21033
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
CHU
Nice, France, 06000
Italy
Fondazionz SAN Raffaele del monte tabor
Milano, Italy, 20132
Dipartimento di Scienze Neurologiche e Psichiatriche
Firenze, Italy, 50134
Hospedal Civile
Gallarate, Italy, 21013
Neuroriabilitazione dell'Università
Genova, Italy, 16132
Clinica Neurologica Università di Torino
Torino, Italy, 10126
Psichiatriche dell'Università di Bari, Policlinico
Bari, Italy, 70122

Sponsors and Collaborators

Rennes University Hospital

Bayer

Wyeth

Farmades, Italy

Investigators

Study Director:

Gilles EDAN, Professor

CHU Rennes

More Information

No publications provided

Study ID Numbers:	981166
Study First Received:	September 16, 2005
Last Updated:	December 21, 2005
ClinicalTrials.gov Identifier:	NCT00219908 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

Multiple sclerosis
Mitoxantrone
Methylprednisolone
Interferon beta1b

Relapse
MRI
EDSS

Study placed in the following topic categories:

Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Methylprednisolone
Interferons
Adjuvants, Immunologic
Interferon-beta
Sclerosis

Multiple Sclerosis, Relapsing-Remitting
Antiviral Agents
Multiple Sclerosis
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis
Sensory System Agents
Therapeutic Uses
Analgesics
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases

Demyelinating Diseases
Nervous System Diseases
Interferon-beta
Adjuvants, Immunologic
Sclerosis
Antiviral Agents
Pharmacologic Actions
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Mitoxantrone
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 01, 2009