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

• Conditions: Multiple Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 16.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2013-001439-34-BE
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-03
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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 LABELLING
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 labelling): 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 significant 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
* Other additional contraindications per local labeling

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified