Status:
COMPLETED
Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs). Secondary Objectives: To describe di...
Detailed 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 elimi...
Eligibility Criteria
Inclusion
- 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.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT01895335
Start Date
June 1 2013
End Date
November 1 2015
Last Update
December 6 2016
Active Locations (169)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number 840077
Birmingham, Alabama, United States, 35209
2
Investigational Site Number 840007
Cullman, Alabama, United States
3
Investigational Site Number 840087
Phoenix, Arizona, United States, 85004
4
Investigational Site Number 840114
Phoenix, Arizona, United States, 85008