Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
106 participants
OBSERVATIONAL
2015-11-30
2021-06-28
Brief Summary
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Detailed Description
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The study will include 300 participants from three Multiple Sclerosis (MS) Clinics. Disease and magnetic resonance imaging (MRI) activity, blood tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), complete blood count (CBC)), drug compliance, side effects, toxicity, will be monitored.
MS patients never treated with a disease modifying drug (DMD) and MS patients previously exposed to another DMD will be included. Some would have been on a single medication, while others would have been treated with two or more medications.
The results of the study will provide the patient-perceived global impacts of Teriflunomide on the patient's overall quality of life.
These results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Teriflunomide
Patient-reported outcomes and clinical assessment
Teriflunomide
The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.
Interventions
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Teriflunomide
The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Montreal Neurological Institute and Hospital
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Pierre Duquette
MD
Principal Investigators
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Pierre Duquette, MD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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CHUM
Montreal, Quebec, Canada
Countries
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References
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O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.
Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry. 2009 Feb;8(1):34-5. doi: 10.1002/j.2051-5545.2009.tb00206.x. No abstract available.
Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.
Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.
Nortvedt MW, Riise T. The use of quality of life measures in multiple sclerosis research. Mult Scler. 2003 Feb;9(1):63-72. doi: 10.1191/1352458503ms871oa.
Teriflunomide (Aubagio) (14 mg Film-coated Tablet): Teriflunomide is Indicated as Monotherapy for the Treatment of Patients with Relapsing-Remitting Multiple Sclerosis to Reduce the Frequency of Clinical Exacerbations and to Delay the Accumulation of Physical Disability [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK253634/
Other Identifiers
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CE15.016
Identifier Type: -
Identifier Source: org_study_id
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