Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
NCT00219908
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 | ||||