Clinical trial NCT02490982: Teriflunomide Observational Effectiveness Study
Official title: Teriflunomide Observational Effectiveness Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: Montreal Neurological Institute and Hospital
First posted: 2015-07-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsing Remitting Multiple Sclerosis patients followed at three MS Clinics.

Brief summary: The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic.

Detailed description: Consenting adult RRMS patients, meeting all inclusion criteria and who have been prescribed Teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (QoL), fatigue, and employment.

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.

Eligibility criteria: Inclusion Criteria:

* Consenting Relapsing Remitting Multiple Sclerosis adults with an Expanded Disability Status Scale (EDSS) score ≤ 5.0 who have been prescribed Teriflunomide and who agree to follow study procedures.

Exclusion Criteria:

* Primary progressive or secondary progressive Multiple Sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.

Primary outcomes:
measure: Patient-reported outcome (PRO) scores
timeFrame: one year
Secondary outcomes:
measure: Disease activity - Composite measure
timeFrame: one year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Pierre Duquette, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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/