EUCTR2013-001439-34-DE
Active, not recruiting
Not Applicable
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
ConditionsMultiple SclerosisMedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsAubagio
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Genzyme Corporation
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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