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

Phase 2

Terminated

• Conditions: Relapsing-Remitting Multiple Sclerosis

• Registration Number: NCT00219908
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Last Update Submitted: 2005-12-21
• Last Update Posted: 2005-12-22
• Study Completion: 2006-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Not specified
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to confirmed progression of at least one EDSS point during the 3 years of the study.

Secondary Outcome Measures

Name	Time	Method
- 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).

Trial Locations

Locations (23)

Centre Guy de Chauliac; 🇫🇷 Montpellier, France

Pierre Weitheimer Hospital; 🇫🇷 Lyon, France

Hôpital Cote de Nacre; 🇫🇷 Caen, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Henri Mondor; 🇫🇷 Creteil, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Institut Catholique de Lille; 🇫🇷 Lomme, France

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

Hôpital Général; 🇫🇷 Dijon, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Chu Timone; 🇫🇷 Marseille, France

CHU Hôpital Central; 🇫🇷 Nancy, France

Hôpital Saint-Anne; 🇫🇷 Paris, France

Centre Fondation Rotschild; 🇫🇷 Paris, France

Psichiatriche dell'Università di Bari, Policlinico; 🇮🇹 Bari, Italy

CHU; 🇫🇷 Nice, France

CHU Pitié-Salpétrière; 🇫🇷 Paris, France

Tenon Hospital; 🇫🇷 Paris, France

CHU Purpan; 🇫🇷 Toulouse, France

Clinica Neurologica Università di Torino; 🇮🇹 Torino, Italy