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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219908

Enrollment

124

Registered

2005-09-22

Start date

1999-07-31

Completion date

2006-06-30

Last updated

2005-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple sclerosis, Mitoxantrone, Methylprednisolone, Interferon beta1b, Relapse, MRI, EDSS

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.

Interventions

DRUGMitoxantrone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to confirmed progression of at least one EDSS point during the 3 years of the study.	—

Secondary

Measure	Time frame
- 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).	—

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026