- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065727
Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis (IQUALYSEP)
November 30, 2012 updated by: Rennes University Hospital
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
Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Le Page Emmanuelle, MD
- Phone Number: 33-2-9928-5296
- Email: emmanuelle.lepage@chu-rennes.fr
Study Locations
-
-
-
Brest, France, 29609
- Recruiting
- CHU Cavale Blanche
-
Contact:
- Rouhart Francois, MD
- Email: francois.rouhart@chu-brest.fr
-
Rennes, France, 35033
- Recruiting
- Chu Rennes
-
Contact:
- Emmauelle Le Page, MD
- Email: emmanuelle.lepage@chu-rennes.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mitoxantrone followed by immunomodulator
|
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
|
Active Comparator: natalizumab
|
monthly natalizumab during 3 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cost effectiveness
Time Frame: 30 years
|
30 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progressive neurological disability
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edan Gilles, MD PhD, Rennes University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Anticipated)
February 1, 2016
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
February 8, 2010
First Submitted That Met QC Criteria
February 8, 2010
First Posted (Estimate)
February 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 3, 2012
Last Update Submitted That Met QC Criteria
November 30, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Aggression
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Immunologic Factors
- Natalizumab
- Mitoxantrone
- Adjuvants, Immunologic
Other Study ID Numbers
- PHRC/09-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on mitoxantrone - immunomodulator
-
Mologen AGCompletedAdvanced Colorectal CarcinomaUnited Kingdom, Germany, Austria, Czech Republic, France, Russian Federation
-
Tatyasaheb Kore Dental CollegeCompletedChronic PeriodontitisIndia
-
PD Dr. Andrew ChanUnknown
-
Institute of Hematology & Blood Diseases Hospital...CSPC Ouyi Pharmaceutical Co., Ltd.Active, not recruiting
-
British Columbia Cancer AgencyCanadian Cancer Society (CCS)Completed
-
Huijing WuBeijing Xisike Clinical Oncology Research Foundation; CSPC Pharmaceutical GroupRecruitingAngioimmunoblastic T-cell LymphomaChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingPeripheral T Cell LymphomaChina
-
University of Sao PauloUnknownCarcinoma, Basal CellBrazil
-
Hui ZengCSPC Ouyi Pharmaceutical Co., Ltd.RecruitingRelapsed or Refractory Acute Myeloid LeukemiaChina
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Withdrawn