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

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Collaborators: Bayer; Farmades, Italy; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Interferon beta-1b; Interferon-beta; Interferons; Mitoxantrone

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