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

Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: Mitoxantrone (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Gilles EDAN, Professor, Study Director, Affiliation: CHU Rennes

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.

Clinical Details

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

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

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

Secondary outcome:

- 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).

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Hôpital Cote de Nacre, Caen 14033, France

Hôpital Gabriel Montpied, Clermont-Ferrand 63003, France

CHU Henri Mondor, Creteil 94000, France

Hôpital Général, Dijon 21033, France

CHU Limoges, Limoges 87042, France

Institut Catholique de Lille, Lomme 59462, France

Pierre Weitheimer Hospital, Lyon 69394, France

Chu Timone, Marseille 13385, France

Centre Guy de Chauliac, Montpellier 34295, France

CHU Hôpital Central, Nancy 54035, France

CHU, Nice 06000, France

Centre Fondation Rotschild, Paris 75019, France

CHU Pitié-Salpétrière, Paris 75013, France

Hôpital Saint-Anne, Paris 75014, France

Tenon Hospital, Paris 759170, France

CHU Strasbourg, Strasbourg 67000, France

CHU Purpan, Toulouse 31059, France

Psichiatriche dell'Università di Bari, Policlinico, Bari 70122, Italy

Dipartimento di Scienze Neurologiche e Psichiatriche, Firenze 50134, Italy

Hospedal Civile, Gallarate 21013, Italy

Neuroriabilitazione dell'Università, Genova 16132, Italy

Fondazionz SAN Raffaele del monte tabor, Milano 20132, Italy

Clinica Neurologica Università di Torino, Torino 10126, Italy

Additional Information

Starting date: July 1999
Last updated: December 21, 2005

Page last updated: August 23, 2015

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