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Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: mitoxantrone - immunomodulator (Other); natalizumab (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Edan Gilles, MD PhD, Principal Investigator, Affiliation: Rennes University Hospital

Overall contact:
Le Page Emmanuelle, MD, Phone: 33-2-9928-5296, Email: emmanuelle.lepage@chu-rennes.fr

Summary

Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

Clinical Details

Official title: Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Primary outcome: cost effectiveness

Secondary outcome: progressive neurological disability

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with remitting multiple sclerosis according to mac Donald criteria

- aggressive remitting multiple sclerosis according to following criteria:

- 2 or less disabling relapse during the 12 months before inclusion

- 1 or more

- EDSS between 2 and 5

- aged less or equal to 40 years old for the women

- effective contraception

Exclusion Criteria:

- patients less than 18 years old

Locations and Contacts

Le Page Emmanuelle, MD, Phone: 33-2-9928-5296, Email: emmanuelle.lepage@chu-rennes.fr

CHU Cavale Blanche, Brest 29609, France; Recruiting
Rouhart Francois, MD, Email: francois.rouhart@chu-brest.fr

CHU Rennes, Rennes 35033, France; Recruiting
Emmauelle Le Page, MD, Email: emmanuelle.lepage@chu-rennes.fr

Additional Information

Starting date: February 2010
Last updated: November 30, 2012

Page last updated: August 23, 2015

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