Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
NCT00219908
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) | |||
Condition ICMJE | Relapsing-Remitting Multiple Sclerosis | |||
Intervention ICMJE | Drug: Mitoxantrone | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | 124 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE | Not Provided | |||
Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00219908 | |||
Other Study ID Numbers ICMJE | 981166 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Rennes University Hospital | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | Rennes University Hospital | |||
Verification Date | September 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |