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

This study has been terminated.

Sponsor:

Collaborators:

Bayer

Wyeth is now a wholly owned subsidiary of Pfizer

Farmades, Italy

Information provided by:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT00219908

First received: September 16, 2005

Last updated: December 21, 2005

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

December 21, 2005

Start Date ^ICMJE

July 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219908 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Relapsing-Remitting Multiple Sclerosis

Intervention ^ICMJE

Drug: Mitoxantrone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

124

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Not Provided

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Italy

Administrative Information

NCT Number ^ICMJE

NCT00219908

Other Study ID Numbers ^ICMJE

981166

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Rennes University Hospital

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Director:

Gilles EDAN, Professor

CHU Rennes

Information Provided By

Rennes University Hospital

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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