Teriflunomide Observational Effectiveness Study

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

Teriflunomide Observational Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490982
• Other study ID #: CE15.016
• Status: Completed
• Start date: November 2015
• Est. completion date: June 28, 2021

Study information

• Verified date: August 2021
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 28, 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis

Intervention

Drug:
• Teriflunomide
The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.

Locations

Country	Name	City	State
Canada	CHUM	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Genzyme, a Sanofi Company, Montreal Neurological Institute and Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View Citation

Nortvedt MW, Riise T. The use of quality of life measures in multiple sclerosis research. Mult Scler. 2003 Feb;9(1):63-72. Review. — View 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. — View Citation

Rush AJ. The role of efficacy and effectiveness trials. World Psychiatry. 2009 Feb;8(1):34-5. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported outcome (PRO) scores	Change on patient-reported outcome measures, from baseline score and at each visit.	one year
Secondary	Disease activity - Composite measure	Change in the annualized relapse-rate and the Expanded Disability Status Scale (EDSS) over the two year period.	one year