Clinical trial NCT00219908: Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple sclerosis
Mitoxantrone
Methylprednisolone
Interferon beta1b
Relapse
MRI
EDSS
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Farmades, Italy
First posted: 2005-09-22
Enrollment: 124
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Time to confirmed progression of at least one EDSS point during the 3 years of the study.
Secondary outcomes:
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,
measure: - annual rate of relapse;
measure: - percentage of relapse-free patients during the study period,
measure: - quality of life,
measure: - 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).
Other outcomes:
Locations:
city: Caen
country: France
facility: Hôpital Cote de Nacre
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Creteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: Hôpital Général
city: Limoges
country: France
facility: CHU Limoges
city: Lomme
country: France
facility: Institut Catholique de Lille
city: Lyon
country: France
facility: Pierre Weitheimer Hospital
city: Marseille
country: France
facility: Chu Timone
city: Montpellier
country: France
facility: Centre Guy de Chauliac
city: Nancy
country: France
facility: CHU Hôpital Central
city: Nice
country: France
facility: CHU
city: Paris
country: France
facility: CHU Pitié-Salpétrière
city: Paris
country: France
facility: Hôpital Saint-Anne
city: Paris
country: France
facility: Centre Fondation Rotschild
city: Paris
country: France
facility: Tenon Hospital
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Purpan
city: Bari
country: Italy
facility: Psichiatriche dell'Università di Bari, Policlinico
city: Firenze
country: Italy
facility: Dipartimento di Scienze Neurologiche e Psichiatriche
city: Gallarate
country: Italy
facility: Hospedal Civile
city: Genova
country: Italy
facility: Neuroriabilitazione dell'Università
city: Milano
country: Italy
facility: Fondazionz SAN Raffaele del monte tabor
city: Torino
country: Italy
facility: Clinica Neurologica Università di Torino
Study officials:
affiliation: CHU Rennes
name: Gilles EDAN, Professor
role: STUDY_DIRECTOR
References: