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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00219908
• Other study ID #: 981166
• Status: Terminated
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: December 21, 2005
• Start date: July 1999
• Est. completion date: June 2006

Study information

• Verified date: September 2005
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Mitoxantrone

Locations

Country	Name	City	State
France	Hôpital Cote de Nacre	Caen
France	Hôpital Gabriel Montpied	Clermont-Ferrand
France	CHU Henri Mondor	Creteil
France	Hôpital Général	Dijon
France	CHU Limoges	Limoges
France	Institut Catholique de Lille	Lomme
France	Pierre Weitheimer Hospital	Lyon
France	Chu Timone	Marseille
France	Centre Guy de Chauliac	Montpellier
France	CHU Hôpital Central	Nancy
France	CHU	Nice
France	Centre Fondation Rotschild	Paris
France	CHU Pitié-Salpétrière	Paris
France	Hôpital Saint-Anne	Paris
France	Tenon Hospital	Paris
France	CHU Strasbourg	Strasbourg
France	CHU Purpan	Toulouse
Italy	Psichiatriche dell'Università di Bari, Policlinico	Bari
Italy	Dipartimento di Scienze Neurologiche e Psichiatriche	Firenze
Italy	Hospedal Civile	Gallarate
Italy	Neuroriabilitazione dell'Università	Genova
Italy	Fondazionz SAN Raffaele del monte tabor	Milano
Italy	Clinica Neurologica Università di Torino	Torino

Sponsors (4)

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

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to confirmed progression of at least one EDSS point during the 3 years of the study.
Secondary	- 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,
Secondary	- annual rate of relapse;
Secondary	- percentage of relapse-free patients during the study period,
Secondary	- quality of life,
Secondary	- 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).