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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis

Treatments

Drug: Teriflunomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01895335

U1111-1139-8730 (Other Identifier)

LPS13567

Details and patient eligibility

About

Primary Objective:

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

Secondary Objectives:

To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.

To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant 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 Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

Full description

The total duration of the study per participant was 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 was possible and it was particularly recommended for women of child-bearing potential.

Enrollment

1,001 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with a relapsing form of multiple sclerosis (RMS) having signed written informed consent.

Exclusion criteria

According to local labelling,
Less than 18 years of age,
Current or history of receiving teriflunomide,
Previous treatment with leflunomide within 6 months prior to baseline,
Participants 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, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
Women who were pregnant or breast-feeding,
Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
Additional exclusion criteria applicable for Europe (EU) countries (in accordance with contraindications of EU summary of product characteristics [SmPC]):
- Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
- Participants with severe active infection until resolution,
- Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
- Participants 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.