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

This study has been terminated.

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

Sponsor:	Rennes University Hospital
Collaborators:	Bayer Wyeth is now a wholly owned subsidiary of Pfizer 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
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
Hôpital Cote de Nacre
Caen, France, 14033
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
CHU Henri Mondor
Creteil, France, 94000
Hôpital Général
Dijon, France, 21033
CHU Limoges
Limoges, France, 87042
Institut Catholique de Lille
Lomme, France, 59462
Pierre Weitheimer Hospital
Lyon, France, 69394
Chu Timone
Marseille, France, 13385
Centre Guy de Chauliac
Montpellier, France, 34295
CHU Hôpital Central
Nancy, France, 54035
CHU
Nice, France, 06000
Centre Fondation Rotschild
Paris, France, 75019
Hôpital Saint-Anne
Paris, France, 75014
CHU Pitié-Salpétrière
Paris, France, 75013
Tenon Hospital
Paris, France, 759170
CHU Strasbourg
Strasbourg, France, 67000
CHU Purpan
Toulouse, France, 31059
Italy
Psichiatriche dell'Università di Bari, Policlinico
Bari, Italy, 70122
Dipartimento di Scienze Neurologiche e Psichiatriche
Firenze, Italy, 50134
Hospedal Civile
Gallarate, Italy, 21013
Neuroriabilitazione dell'Università
Genova, Italy, 16132
Fondazionz SAN Raffaele del monte tabor
Milano, Italy, 20132
Clinica Neurologica Università di Torino
Torino, Italy, 10126

Sponsors and Collaborators

Rennes University Hospital

Bayer

Wyeth is now a wholly owned subsidiary of Pfizer

Farmades, Italy

Investigators

Study Director:

Gilles EDAN, Professor

CHU Rennes

More Information

No publications provided

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

Keywords provided by Rennes University Hospital:

Multiple sclerosis
Mitoxantrone
Methylprednisolone
Interferon beta1b

Relapse
MRI
EDSS

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b

Mitoxantrone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012