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

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ClinicalTrials.gov Identifier: NCT01895335
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Intervention Drug: Teriflunomide
Enrollment 1001
Recruitment Details The study was conducted at 169 centers in 14 countries. A total of 1102 participants were screened between June 14, 2013 and November 27, 2014 of whom 101 were screen failures. Screen failures were mainly due to exclusion criteria met.
Pre-assignment Details A total of 1001 participants were included and 1000 participants were treated in the study. Dose of Teriflunomide tablet was given according to local labelling 14 mg or 7 mg (Teriflunomide 14 mg was the recommended dosage worldwide, except in the US [where both 7 mg and 14 mg were available]).
Arm/Group Title Teriflunomide
Hide Arm/Group Description Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
Period Title: Overall Study
Started 1001
Treated 1000
Completed 786
Not Completed 215
Reason Not Completed
Adverse Event             106
Lack of Efficacy             53
Poor Compliance to Protocol             11
Included But Not treated             1
Other than Specified Above             44
Arm/Group Title Teriflunomide
Hide Arm/Group Description Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Baseline Participants 1000
Hide Baseline Analysis Population Description
Baseline population included all treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1000 participants
47.1  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1000 participants
Female
756
  75.6%
Male
244
  24.4%
1.Primary Outcome
Title Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 – Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48
Hide Description

TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14).

Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 889
Mean (Standard Deviation)
Unit of Measure: units on a scale
68.17  (27.66)
2.Secondary Outcome
Title Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48
Hide Description TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .
Time Frame Baseline, Week 4, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 594
Mean (Standard Deviation)
Unit of Measure: units on a scale
Global Satisfaction Score Change at Week 4 (n=482) 21.35  (27.51)
Global Satisfaction Score Change at Week 48(n=457) 16.55  (34.29)
Effectiveness Score Change at Week 4 (n=477) 12.02  (25.53)
Effectiveness Score Change at Week 48 (n=453) 10.19  (28.90)
Side effects Score Change at Week 4 (n=479) 24.31  (35.47)
Side effects Score Change at Week 48 (n=456) 19.95  (39.00)
Convenience Score Change at Week 4 (n=487) 34.64  (26.37)
Convenience Score Change at Week 48 (n=461) 32.21  (27.01)
3.Secondary Outcome
Title Change From Week 4 in TSQM Scores in Naïve Participants to Week 48
Hide Description TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.
Time Frame Week 4, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 285
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change in Global Satisfaction Score (n=234) -1.34  (23.59)
Change in Effectiveness Score (n=231) 1.76  (27.48)
Change in Side effects Score (n=234) -5.44  (25.11)
Change in Convenience Score (n=235) 0.33  (12.96)
4.Secondary Outcome
Title Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48
Hide Description PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 860
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.01  (1.05)
5.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48
Hide Description MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.
Time Frame Baseline, Week 24, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Here, ‘n’ signifies number of participants with available data at specified time points.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 24 (n=854) -0.61  (3.89)
Change at Week 48 (n=875) -0.06  (4.33)
6.Secondary Outcome
Title Annualized Treated Relapse Rate
Hide Description Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.
Time Frame Baseline up to end of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Measure Type: Number
Unit of Measure: relapses per patient-year
0.200
7.Secondary Outcome
Title Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48
Hide Description A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.
Time Frame Baseline up to end of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability of treated relapse
Percent Probability of Treated Relapse at Week 4
1.8
(1.0 to 2.6)
Percent Probability of Treated Relapse at Week 24
9.4
(7.5 to 11.2)
Percent Probability of Treated Relapse at Week 48
15.5
(13.2 to 17.9)
8.Secondary Outcome
Title Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48
Hide Description SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 854
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.00  (0.06)
9.Secondary Outcome
Title Overview of Adverse Events (AEs)
Hide Description Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Time Frame From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 82.3
Any treatment emergent SAE 12.7
Any TEAE leading to death 0.4
Any TEAE leading to permanent discontinuation 10.9
10.Secondary Outcome
Title Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period
Hide Description Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.
Time Frame Baseline up to end of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety population.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Measure Type: Number
Unit of Measure: percentage of participants
98.2
11.Secondary Outcome
Title Duration of Teriflunomide Treatment Exposure
Hide Description Duration of exposure was defined as last dose date – first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).
Time Frame Baseline up to end of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety population.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Mean (Standard Deviation)
Unit of Measure: Days
301.6  (89.1)
12.Secondary Outcome
Title Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48
Hide Description The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 826
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.99  (10.82)
13.Secondary Outcome
Title Change From Baseline in Stern Leisure Activity Scale at Week 48
Hide Description The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant’s participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 845
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.07  (1.93)
14.Secondary Outcome
Title Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48
Hide Description EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.
Time Frame Baseline, Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.
Arm/Group Title Teriflunomide
Hide Arm/Group Description:
Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
Overall Number of Participants Analyzed 1000
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=981) 3.05  (1.94)
Week 48 (n=886) 3.05  (1.98)
Time Frame All AEs were collected from signature of the informed consent form up to the last visit (Week 52) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are TEAEs that is AEs that developed/worsened from first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants in AEP. Analysis was performed on safety population.
 
Arm/Group Title Teriflunomide
Hide Arm/Group Description Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
All-Cause Mortality
Teriflunomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Teriflunomide
Affected / at Risk (%)
Total   127/1000 (12.70%) 
Blood and lymphatic system disorders   
Neutropenia  1  1/1000 (0.10%) 
Cardiac disorders   
Acute Myocardial Infarction  1  1/1000 (0.10%) 
Coronary Artery Disease  1  1/1000 (0.10%) 
Myocardial Infarction  1  1/1000 (0.10%) 
Myocarditis  1  1/1000 (0.10%) 
Ear and labyrinth disorders   
Vertigo  1  1/1000 (0.10%) 
Eye disorders   
Blindness Unilateral  1  1/1000 (0.10%) 
Retinal Artery Thrombosis  1  1/1000 (0.10%) 
Gastrointestinal disorders   
Abdominal Hernia Obstructive  1  1/1000 (0.10%) 
Colitis Microscopic  1  1/1000 (0.10%) 
Diarrhoea  1  1/1000 (0.10%) 
Dysphagia  1  1/1000 (0.10%) 
Gastritis  1  2/1000 (0.20%) 
Gastrooesophageal Reflux Disease  1  2/1000 (0.20%) 
Hiatus Hernia  1  2/1000 (0.20%) 
Volvulus  1  1/1000 (0.10%) 
General disorders   
Asthenia  1  1/1000 (0.10%) 
Chest Pain  1  3/1000 (0.30%) 
Non-Cardiac Chest Pain  1  3/1000 (0.30%) 
Oedema Peripheral  1  1/1000 (0.10%) 
Hepatobiliary disorders   
Bile Duct Stone  1  1/1000 (0.10%) 
Biliary Colic  1  1/1000 (0.10%) 
Cholecystitis  1  2/1000 (0.20%) 
Cholelithiasis  1  1/1000 (0.10%) 
Immune system disorders   
Hypersensitivity  1  1/1000 (0.10%) 
Infections and infestations   
Appendicitis  1  1/1000 (0.10%) 
Cellulitis  1  1/1000 (0.10%) 
Clostridium Difficile Colitis  1  1/1000 (0.10%) 
Clostridium Difficile Infection  1  1/1000 (0.10%) 
Diverticulitis  1  2/1000 (0.20%) 
Gastroenteritis  1  2/1000 (0.20%) 
Myelitis  1  1/1000 (0.10%) 
Oesophageal Candidiasis  1  1/1000 (0.10%) 
Osteomyelitis  1  1/1000 (0.10%) 
Pelvic Abscess  1  1/1000 (0.10%) 
Perichondritis  1  1/1000 (0.10%) 
Pneumonia  1  4/1000 (0.40%) 
Pyelonephritis  1  1/1000 (0.10%) 
Sepsis  1  1/1000 (0.10%) 
Urinary Tract Infection  1  5/1000 (0.50%) 
Viral Infection  1  1/1000 (0.10%) 
Viral Upper Respiratory Tract Infection  1  1/1000 (0.10%) 
Injury, poisoning and procedural complications   
Accidental Overdose  1  1/1000 (0.10%) 
Facial Bones Fracture  1  1/1000 (0.10%) 
Intentional Overdose  1  1/1000 (0.10%) 
Investigations   
Alanine Aminotransferase Increased  1  6/1000 (0.60%) 
Blood Pressure Increased  1  1/1000 (0.10%) 
Clostridium Test Positive  1  1/1000 (0.10%) 
Fibrin D Dimer Increased  1  1/1000 (0.10%) 
Transaminases Increased  1  1/1000 (0.10%) 
Weight Decreased  1  2/1000 (0.20%) 
Metabolism and nutrition disorders   
Diabetic Ketoacidosis  1  1/1000 (0.10%) 
Hypokalaemia  1  1/1000 (0.10%) 
Metabolic Acidosis  1  1/1000 (0.10%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  1/1000 (0.10%) 
Cervical Spinal Stenosis  1  1/1000 (0.10%) 
Intervertebral Disc Disorder  1  1/1000 (0.10%) 
Intervertebral Disc Protrusion  1  1/1000 (0.10%) 
Musculoskeletal Pain  1  1/1000 (0.10%) 
Osteoarthritis  1  1/1000 (0.10%) 
Periarthritis  1  1/1000 (0.10%) 
Rhabdomyolysis  1  1/1000 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma  1  2/1000 (0.20%) 
Breast Cancer  1  1/1000 (0.10%) 
Fibroma  1  1/1000 (0.10%) 
Invasive Ductal Breast Carcinoma  1  1/1000 (0.10%) 
Malignant Melanoma  1  1/1000 (0.10%) 
Non-Small Cell Lung Cancer Stage Iv  1  1/1000 (0.10%) 
Rectal Cancer  1  1/1000 (0.10%) 
Uterine Leiomyoma  1  2/1000 (0.20%) 
Nervous system disorders   
Carpal Tunnel Syndrome  1  1/1000 (0.10%) 
Cerebral Sarcoidosis  1  1/1000 (0.10%) 
Cerebrovascular Accident  1  1/1000 (0.10%) 
Cervicobrachial Syndrome  1  1/1000 (0.10%) 
Encephalopathy  1  1/1000 (0.10%) 
Epilepsy  1  1/1000 (0.10%) 
Headache  1  1/1000 (0.10%) 
Hemiparesis  1  1/1000 (0.10%) 
Hypoaesthesia  1  1/1000 (0.10%) 
Medication Overuse Headache  1  1/1000 (0.10%) 
Multiple Sclerosis  1  2/1000 (0.20%) 
Multiple Sclerosis Relapse  1  21/1000 (2.10%) 
Neuromyelitis Optica  1  1/1000 (0.10%) 
Paraesthesia  1  1/1000 (0.10%) 
Seizure  1  1/1000 (0.10%) 
Syncope  1  4/1000 (0.40%) 
Toxic Encephalopathy  1  1/1000 (0.10%) 
Transient Ischaemic Attack  1  1/1000 (0.10%) 
Trigeminal Neuralgia  1  2/1000 (0.20%) 
Uhthoff's Phenomenon  1  1/1000 (0.10%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy  1  1/1000 (0.10%) 
Psychiatric disorders   
Acute Psychosis  1  1/1000 (0.10%) 
Adjustment Disorder With Depressed Mood  1  1/1000 (0.10%) 
Depression  1  2/1000 (0.20%) 
Suicidal Ideation  1  1/1000 (0.10%) 
Suicide Attempt  1  2/1000 (0.20%) 
Renal and urinary disorders   
Acute Kidney Injury  1  2/1000 (0.20%) 
Haematuria  1  1/1000 (0.10%) 
Hypertonic Bladder  1  1/1000 (0.10%) 
Nephrolithiasis  1  1/1000 (0.10%) 
Reproductive system and breast disorders   
Female Genital Tract Fistula  1  1/1000 (0.10%) 
Menorrhagia  1  1/1000 (0.10%) 
Ovarian Cyst  1  2/1000 (0.20%) 
Respiratory, thoracic and mediastinal disorders   
Acute Interstitial Pneumonitis  1  1/1000 (0.10%) 
Acute Respiratory Failure  1  2/1000 (0.20%) 
Asthmatic Crisis  1  1/1000 (0.10%) 
Atelectasis  1  1/1000 (0.10%) 
Chronic Obstructive Pulmonary Disease  1  1/1000 (0.10%) 
Lung Cyst  1  1/1000 (0.10%) 
Pneumonia Aspiration  1  1/1000 (0.10%) 
Pulmonary Embolism  1  1/1000 (0.10%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/1000 (0.10%) 
Eczema  1  1/1000 (0.10%) 
Psoriasis  1  1/1000 (0.10%) 
Rash  1  1/1000 (0.10%) 
Surgical and medical procedures   
Abdominoplasty  1  1/1000 (0.10%) 
Vascular disorders   
Deep Vein Thrombosis  1  1/1000 (0.10%) 
Essential Hypertension  1  1/1000 (0.10%) 
Hypertension  1  6/1000 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Teriflunomide
Affected / at Risk (%)
Total   498/1000 (49.80%) 
Gastrointestinal disorders   
Diarrhoea  1  172/1000 (17.20%) 
Nausea  1  82/1000 (8.20%) 
General disorders   
Fatigue  1  52/1000 (5.20%) 
Infections and infestations   
Nasopharyngitis  1  54/1000 (5.40%) 
Urinary Tract Infection  1  62/1000 (6.20%) 
Investigations   
Alanine Aminotransferase Increased  1  57/1000 (5.70%) 
Nervous system disorders   
Headache  1  68/1000 (6.80%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  229/1000 (22.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01895335     History of Changes
Other Study ID Numbers: LPS13567
U1111-1139-8730 ( Other Identifier: UTN )
First Submitted: July 3, 2013
First Posted: July 10, 2013
Results First Submitted: October 10, 2016
Results First Posted: December 6, 2016
Last Update Posted: December 6, 2016