Teriflunomide Observational Effectiveness Study | NCT02490982

Studies
Teriflunomide Observational Effectiveness Study

NCT02490982

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Last Update Posted

Aug 18, 2021Actual

Enrollment

106Actual

Phase

Not provided

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Teriflunomide

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Jun 28, 2021Actual

First Submitted Date

Jun 26, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2021

Last Update Posted Date

Aug 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pierre Duquette, MD, Centre hospitalier de l'Université de Montréal (CHUM)Principal Investigator

Lead Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

Collaborators

Name	Class
Genzyme, a Sanofi Company	INDUSTRY
Montreal Neurological Institute and Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teriflunomide		Patient-reported outcomes and clinical assessment	Drug: Teriflunomide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teriflunomide	Drug	The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.	Teriflunomide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient-reported outcome (PRO) scores	Change on patient-reported outcome measures, from baseline score and at each visit.	one year

Secondary Outcomes

Measure	Description	Time Frame
Disease activity - Composite measure	Change in the annualized relapse-rate and the Expanded Disability Status Scale (EDSS) over the two year period.	one year

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Relapsing Remitting Multiple Sclerosis patients followed at three MS Clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Duquette, MD	Centre hospitalier de l'Université de Montréal (CHUM)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUM		Montreal	Quebec	H2L 4M1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21991951	Background	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.
19293957	Background

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases