Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis (IQUALYSEP)
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ClinicalTrials.gov Identifier: NCT01065727 |
Recruitment Status : Unknown
Verified November 2012 by Rennes University Hospital.
Recruitment status was: Recruiting
First Posted : February 9, 2010
Last Update Posted : December 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Other: mitoxantrone - immunomodulator Other: natalizumab | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Health Services Research |
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 Start Date : | February 2010 |
Estimated Primary Completion Date : | February 2016 |
Estimated Study Completion Date : | February 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: mitoxantrone followed by immunomodulator |
Other: mitoxantrone - immunomodulator
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half |
Active Comparator: natalizumab |
Other: natalizumab
monthly natalizumab during 3 years |
- cost effectiveness [ Time Frame: 30 years ]
- progressive neurological disability [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065727
Contact: Le Page Emmanuelle, MD | 33-2-9928-5296 | emmanuelle.lepage@chu-rennes.fr |
France | |
CHU Cavale Blanche | Recruiting |
Brest, France, 29609 | |
Contact: Rouhart Francois, MD francois.rouhart@chu-brest.fr | |
CHU Rennes | Recruiting |
Rennes, France, 35033 | |
Contact: Emmauelle Le Page, MD emmanuelle.lepage@chu-rennes.fr |
Principal Investigator: | Edan Gilles, MD PhD | Rennes University Hospital |
Responsible Party: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT01065727 |
Other Study ID Numbers: |
PHRC/09-06 |
First Posted: | February 9, 2010 Key Record Dates |
Last Update Posted: | December 3, 2012 |
Last Verified: | November 2012 |
Reemitting aggressive multiple sclerosis |
Multiple Sclerosis Sclerosis Aggression Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Behavioral Symptoms Mitoxantrone |
Natalizumab Immunologic Factors Adjuvants, Immunologic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |