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

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2013-001439-34-FI
• Date of registration: 19/09/2013
• Prospective Registration: Yes
• Primary sponsor: Genzyme Corporation
• Public title: Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
• Scientific 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 - TERI-PRO
• Date of first enrolment: 18/11/2013
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001439-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Belgium, Canada, Chile, Finland, Germany, Greece, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Study Unit
• Affiliation: Sanofi-aventis Oy

• Name: Clinical Study Unit
• Affiliation: Sanofi-aventis Oy

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients with a relapsing form of MS (RMS)
- Having signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 930
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion criteria:
- ACCORDING TO LOCAL LABELING
- 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, either diagnosed by standard medical practice and guidelines (including skin or blood test, as appropriate) or according to local labeling
- 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, leucopenia, 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple Sclerosis
MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Aubagio
Product Name: Teriflunomide
Product Code: HMR1726
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TERIFLUNOMIDE
CAS Number: 108605-62-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-

Primary Outcome(s)

Main Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of PROs

Primary end point(s): Assessment at 48 weeks (W48/EOT) of global satisfaction with teriflunomide treatment, measured by the Treatment Satisfaction Questionnaire for Medicine (TSQM) version 1.4 score

Secondary Objective: - To describe disease progression using PRO
- 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 event 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) (1) and expanded disability status scale (EDSS) (2) in assessing MS disease progression

Timepoint(s) of evaluation of this end point: 48 weeks

Secondary Outcome(s)

Secondary end point(s): 1 - Change in TSQM version 1.4 from baseline to W4 and to W48/EOT of teriflunomide treatment in patients switching from another DMT
2 - Change in TSQM version 1.4 from W4 to W48/EOT in naïve patients
3 - Disease progression: change from baseline to W48/EOT of teriflunomide treatment, measured by the Patient Determined Disease Steps (PDDS) scale
4 - Disease progression: change from baseline to W24 and to W48/EOT of teriflunomide treatment, measured by the Multiple Sclerosis Performance Scale (MSPS) score (4, 5)
5 - Clinical outcomes: treated relapse, time to first treated relapse
6 - Change in cognition: change from baseline to W48/EOT of teriflunomide treatment as measured by the Symbol Digit Modalities Test (SDMT) score
7 - Occurrence of adverse events (AEs) based on AE reporting at each visit
8 - Adherence (ie, compliance) and persistence (ie, duration of exposure) to teriflunomide treatment over 48 weeks
9 - Quality of life: change from baseline to W48/EOT of teriflunomide treatment, measured by the Multiple Sclerosis International Quality of Life (MusiQoL) score (6) and Stern leisure activity scale (7).
10 - EDSS score at baseline and at W48/EOT

Timepoint(s) of evaluation of this end point: 1 - Baseline to W4 and W4 to W48
2 - W4 to W48
3 - Baseline to W48
4 - Baseline to W24 and W24 to W48
5 - Over 48 weeks
6 - Baseline to W48
7/8 - Over 48 weeks
9 - Baseline to W48
10 - At baseline and at W48

Secondary ID(s)

LPS13567

Source(s) of Monetary Support

Genzyme Corporation