Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients (TERI-PRO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01895335
First received: July 3, 2013
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs).

Secondary Objectives:

To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients.

To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting).

To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.

To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.


Condition Intervention Phase
Multiple Sclerosis
Drug: TERIFLUNOMIDE HMR1726
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment at 48 weeks of global satisfaction with teriflunomide treatment, measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from baseline to week 4 (W4) and to week 48 (W48) in patients switching from another Disease Modifying Therapy (DMT) [ Time Frame: Baseline to W4 and W4 to W48 ] [ Designated as safety issue: No ]
  • Change in Treatment Satisfaction Questionnaire for Medicine (TSQM) from W4 to W48 in naïve patients [ Time Frame: W4 to W48 ] [ Designated as safety issue: No ]
  • Change in disease progression from baseline to week 24 (W24) and to W48 of teriflunomide treatment, measured by the Patient Determined Disease Steps (PDDS) [ Time Frame: Baseline to W48 ] [ Designated as safety issue: No ]
  • Change in disease progression from baseline to W24 and to W48 of teriflunomide treatment, measured by the Multiple Sclerosis Performance Scale (MSPS) score [ Time Frame: Baseline to W24 and W24 to W48 ] [ Designated as safety issue: No ]
  • Clinical outcomes: treated relapses, time to first treated relapse [ Time Frame: Over 48 weeks ] [ Designated as safety issue: No ]
  • Change in cognition from baseline to W48 of teriflunomide treatment, measured by the Symbol Digit Modalities Test (SDMT) score [ Time Frame: Baseline to W48 ] [ Designated as safety issue: No ]
  • Overview of adverse events (AEs) based on AE reporting at each visit [ Time Frame: Over 48 weeks ] [ Designated as safety issue: Yes ]
  • Adherence (ie, compliance) and persistence (ie, duration of exposure) to teriflunomide treatment [ Time Frame: Over 48 weeks ] [ Designated as safety issue: No ]
  • Quality of life: change from baseline to W48 of teriflunomide treatment, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) score and Stern Leisure Activity Scale [ Time Frame: Baseline to W48 ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS) score [ Time Frame: At baseline and at W48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriflunomide (HMR1726)
Open label, teriflunomide oral tablet once daily with or without food. Approved in US 7mg or 14 mg once daily oral tablet; Other countries drug approval pending and dose according to local labeling
Drug: TERIFLUNOMIDE HMR1726
Pharmaceutical form:film-coated tablet Route of administration: oral
Other Name: Aubagio

Detailed Description:

The total duration of the study per patient is up to 50 or 54 weeks (if accelerated elimination procedure performed):

Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed)

An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment is possible and it is particularly recommended for women of child-bearing potential.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with a relapsing form of multiple sclerosis (RMS) Having signed written informed consent

Exclusion criteria:

  • ACCORDING TO LOCAL LABELING
  • Less than 18 years of age
  • Current or history of receiving teriflunomide
  • Previous treatment with leflunomide within 6 months prior to baseline
  • Patients with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN)
  • Known history of active tuberculosis (TB) or latent TB infection
  • Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections
  • Women who are pregnant or breast-feeding
  • Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use reliable contraception throughout the course of the study
  • Male patients (only when required according to local labeling): unwilling to use reliable contraception during the course of the study
  • Additional exclusion criteria applicable for EU countries (in accordance with contraindications of EU SmPC):

    • Patients with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia
    • Patients with severe active infection until resolution
    • Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group
    • Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome
  • Hypersensitivity to the active substance or to any of the excipients
  • Other additional contraindications per local labeling The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895335

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 158 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01895335     History of Changes
Other Study ID Numbers: LPS13567, U1111-1139-8730
Study First Received: July 3, 2013
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014