Status:
TERMINATED
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Bayer
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
18-45 years
Phase:
PHASE2
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00219908
Start Date
July 1 1999
End Date
June 1 2006
Last Update
December 22 2005
Active Locations (23)
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1
Hôpital Cote de Nacre
Caen, France, 14033
2
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
3
CHU Henri Mondor
Créteil, France, 94000
4
Hôpital Général
Dijon, France, 21033