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
23
Locations
83
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 DiseaseIntervention/TreatmentPhase
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

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

Secondary Outcome Measures

  1. - 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, []

  2. - annual rate of relapse; []

  3. - percentage of relapse-free patients during the study period, []

  4. - quality of life, []

  5. - 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:
No
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

SiteCityStateCountryPostal Code
1Hôpital Cote de NacreCaenFrance14033
2Hôpital Gabriel MontpiedClermont-FerrandFrance63003
3CHU Henri MondorCreteilFrance94000
4Hôpital GénéralDijonFrance21033
5CHU LimogesLimogesFrance87042
6Institut Catholique de LilleLommeFrance59462
7Pierre Weitheimer HospitalLyonFrance69394
8Chu TimoneMarseilleFrance13385
9Centre Guy de ChauliacMontpellierFrance34295
10CHU Hôpital CentralNancyFrance54035
11CHUNiceFrance06000
12CHU Pitié-SalpétrièreParisFrance75013
13Hôpital Saint-AnneParisFrance75014
14Centre Fondation RotschildParisFrance75019
15Tenon HospitalParisFrance759170
16CHU StrasbourgStrasbourgFrance67000
17CHU PurpanToulouseFrance31059
18Psichiatriche dell'Università di Bari, PoliclinicoBariItaly70122
19Dipartimento di Scienze Neurologiche e PsichiatricheFirenzeItaly50134
20Hospedal CivileGallarateItaly21013
21Neuroriabilitazione dell'UniversitàGenovaItaly16132
22Fondazionz SAN Raffaele del monte taborMilanoItaly20132
23Clinica Neurologica Università di TorinoTorinoItaly10126

Sponsors and Collaborators

  • Rennes University Hospital
  • Bayer
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Farmades, Italy

Investigators

  • Study Director: Gilles EDAN, Professor, CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00219908
Other Study ID Numbers:
  • 981166
First Posted:
Sep 22, 2005
Last Update Posted:
Dec 22, 2005
Last Verified:
Sep 1, 2005

Study Results

No Results Posted as of Dec 22, 2005