Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis (IQUALYSEP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01065727
First received: February 8, 2010
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis |
Other: mitoxantrone - immunomodulator Other: natalizumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Rennes University Hospital:
Primary Outcome Measures:
- cost effectiveness [ Time Frame: 30 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progressive neurological disability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065727
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065727
Contacts
| Contact: Le Page Emmanuelle, MD | 33-2-9928-5296 | emmanuelle.lepage@chu-rennes.fr |
Locations
| 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 | |
Sponsors and Collaborators
Rennes University Hospital
Investigators
| Principal Investigator: | Edan Gilles, MD PhD | Rennes University Hospital |
More Information
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01065727 History of Changes |
| Other Study ID Numbers: | PHRC/09-06 |
| Study First Received: | February 8, 2010 |
| Last Updated: | November 30, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
Reemitting aggressive multiple sclerosis |
Additional relevant MeSH terms:
|
Sclerosis Multiple 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 |
ClinicalTrials.gov processed this record on September 23, 2016