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

Sponsor

Rennes University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00219908

Collaborator

Bayer (Industry), Wyeth is now a wholly owned subsidiary of Pfizer (Industry), Farmades, Italy (Other)

124

Enrollment

Locations

Duration (Months)

5.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Mitoxantrone	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 1999

Study Completion Date :

Jun 1, 2006

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Hôpital Cote de Nacre	Caen	France	14033
2	Hôpital Gabriel Montpied	Clermont-Ferrand	France	63003
3	CHU Henri Mondor	Creteil	France	94000
4	Hôpital Général	Dijon	France	21033
5	CHU Limoges	Limoges	France	87042
6	Institut Catholique de Lille	Lomme	France	59462
7	Pierre Weitheimer Hospital	Lyon	France	69394
8	Chu Timone	Marseille	France	13385
9	Centre Guy de Chauliac	Montpellier	France	34295
10	CHU Hôpital Central	Nancy	France	54035
11	CHU	Nice	France	06000
12	CHU Pitié-Salpétrière	Paris	France	75013
13	Hôpital Saint-Anne	Paris	France	75014
14	Centre Fondation Rotschild	Paris	France	75019
15	Tenon Hospital	Paris	France	759170
16	CHU Strasbourg	Strasbourg	France	67000
17	CHU Purpan	Toulouse	France	31059
18	Psichiatriche dell'Università di Bari, Policlinico	Bari	Italy	70122
19	Dipartimento di Scienze Neurologiche e Psichiatriche	Firenze	Italy	50134
20	Hospedal Civile	Gallarate	Italy	21013
21	Neuroriabilitazione dell'Università	Genova	Italy	16132
22	Fondazionz SAN Raffaele del monte tabor	Milano	Italy	20132
23	Clinica Neurologica Università di Torino	Torino	Italy	10126