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

December 21, 2005 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
- 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Bayer
Farmades, Italy

Investigators

  • Study Director: Gilles EDAN, Professor, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 22, 2005

Last Update Submitted That Met QC Criteria

December 21, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981166

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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