Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1139-8730 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).
Secondary Objectives:
To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.
To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events 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 Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
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 elimination procedure: 4 weeks when performed
An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriflunomide | Experimental | Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriflunomide | Drug | Pharmaceutical form: film-coated tablet; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 | 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. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | 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 . |
Not provided
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]):
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840077 | Birmingham | Alabama | 35209 | United States | ||
| Investigational Site Number 840007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31005729 | Derived | Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Poole EM, Robinson M, Gold R. Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study. Mult Scler Relat Disord. 2019 Jun;31:157-164. doi: 10.1016/j.msard.2019.03.022. Epub 2019 Mar 30. | |
| 29055438 | Derived |
Not provided
Not provided
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]).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Teriflunomide | Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 4, Week 48 |
| Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 | 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. | Week 4, Week 48 |
| Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 | 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. | Baseline, Week 48 |
| Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 | 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. | Baseline, Week 24, Week 48 |
| Annualized Treated Relapse Rate | 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. | Baseline up to end of treatment (up to Week 48) |
| Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 | 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. | Baseline up to end of treatment (up to Week 48) |
| Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 | 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. | Baseline, Week 48 |
| Overview of Adverse Events (AEs) | 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. | 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 |
| Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period | 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. | Baseline up to end of treatment (up to Week 48) |
| Duration of Teriflunomide Treatment Exposure | 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). | Baseline up to end of treatment (up to Week 48) |
| Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48 | 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. | Baseline, Week 48 |
| Change From Baseline in Stern Leisure Activity Scale at Week 48 | 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. | Baseline, Week 48 |
| Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48 | 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. | Baseline, Week 48 |
| Cullman |
| Alabama |
| United States |
| Investigational Site Number 840087 | Phoenix | Arizona | 85004 | United States |
| Investigational Site Number 840114 | Phoenix | Arizona | 85008 | United States |
| Investigational Site Number 840080 | Scottsdale | Arizona | 85258 | United States |
| Investigational Site Number 840032 | Tucson | Arizona | 85704 | United States |
| Investigational Site Number 840021 | Phoenix | Arkansas | United States |
| Investigational Site Number 840018 | Fullerton | California | 92835 | United States |
| Investigational Site Number 840037 | Fullerton | California | 92835 | United States |
| Investigational Site Number 840108 | Long Beach | California | 90806 | United States |
| Investigational Site Number 840014 | Newport Beach | California | 92663 | United States |
| Investigational Site Number 840019 | Oceanside | California | 92056 | United States |
| Investigational Site Number 840097 | Boulder | Colorado | 80304 | United States |
| Investigational Site Number 840040 | Colorado Springs | Colorado | 80907 | United States |
| Investigational Site Number 840046 | Denver | Colorado | CO | United States |
| Investigational Site Number 840016 | Englewood | Colorado | 80113 | United States |
| Investigational Site Number 840094 | Fort Collins | Colorado | 80528 | United States |
| Investigational Site Number 840024 | Bradenton | Florida | FL | United States |
| Investigational Site Number 840089 | Clearwater | Florida | 33756 | United States |
| Investigational Site Number 840055 | Coconut Creek | Florida | 33073 | United States |
| Investigational Site Number 840104 | Hialeah | Florida | 33013 | United States |
| Investigational Site Number 840101 | Miami Lakes | Florida | 33014 | United States |
| Investigational Site Number 840011 | Ormond Beach | Florida | United States |
| Investigational Site Number 840059 | Sarasota | Florida | 34239 | United States |
| Investigational Site Number 840008 | St. Petersburg | Florida | United States |
| Investigational Site Number 840081 | Sunrise | Florida | 33351 | United States |
| Investigational Site Number 840002 | Atlanta | Georgia | 30318 | United States |
| Investigational Site Number 840075 | Macon | Georgia | 31210 | United States |
| Investigational Site Number 840012 | Fort Wayne | Indiana | United States |
| Investigational Site Number 840010 | Indianapolis | Indiana | United States |
| Investigational Site Number 840034 | Louisville | Kentucky | 40207 | United States |
| Investigational Site Number 840047 | Rockport | Maine | 04843 | United States |
| Investigational Site Number 840107 | Foxborough | Massachusetts | 02035 | United States |
| Investigational Site Number 840030 | Springfield | Massachusetts | 01104 | United States |
| Investigational Site Number 840073 | Clinton Township | Michigan | 48035 | United States |
| Investigational Site Number 840068 | Golden Valley | Minnesota | 55422 | United States |
| Investigational Site Number 840098 | Golden Valley | Minnesota | 55422 | United States |
| Investigational Site Number 840086 | Chesterfield | Missouri | 63017 | United States |
| Investigational Site Number 840058 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 840026 | Lincoln | Nebraska | 68521 | United States |
| Investigational Site Number 840020 | Henderson | Nevada | 89012 | United States |
| Investigational Site Number 840049 | Freehold | New Jersey | 07728 | United States |
| Investigational Site Number 840044 | Toms River | New Jersey | 08755 | United States |
| Investigational Site Number 840100 | East Setauket | New York | 11733-345 | United States |
| Investigational Site Number 840064 | New York | New York | 14203 | United States |
| Investigational Site Number 840005 | New York | New York | United States |
| Investigational Site Number 840071 | Schenectady | New York | 12308 | United States |
| Investigational Site Number 840091 | Staten Island | New York | 10306 | United States |
| Investigational Site Number 840045 | Syracuse | New York | 13202 | United States |
| Investigational Site Number 840084 | Asheville | North Carolina | 28806 | United States |
| Investigational Site Number 840078 | Charlotte | North Carolina | 28204 | United States |
| Investigational Site Number 840042 | Raliegh | North Carolina | United States |
| Investigational Site Number 840105 | Sanford | North Carolina | United States |
| Investigational Site Number 840074 | Wilmington | North Carolina | 28401 | United States |
| Investigational Site Number 840090 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 840041 | Bismarck | North Dakota | United States |
| Investigational Site Number 840003 | Canton | Ohio | 44718 | United States |
| Investigational Site Number 840009 | Dayton | Ohio | United States |
| Investigational Site Number 840053 | Monaca | Pennsylvania | 15061 | United States |
| Investigational Site Number 840056 | Philadelphia | Pennsylvania | 19107 | United States |
| Investigational Site Number 840072 | Cranston | Rhode Island | 02920 | United States |
| Investigational Site Number 840048 | Nashville | Tennessee | 37215 | United States |
| Investigational Site Number 840035 | Tullahoma | Tennessee | 37388 | United States |
| Investigational Site Number 840060 | Dallas | Texas | 75246 | United States |
| Investigational Site Number 840052 | Mansfield | Texas | 76063 | United States |
| Investigational Site Number 840028 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number 840070 | Henrico | Virginia | 23226 | United States |
| Investigational Site Number 840109 | Richmond | Virginia | 23298 | United States |
| Investigational Site Number 840017 | Roanoke | Virginia | 24018 | United States |
| Investigational Site Number 840054 | Vienna | Virginia | 22182 | United States |
| Investigational Site Number 840069 | Spokane | Washington | 99220-3649 | United States |
| Investigational Site Number 840079 | Morgantown | West Virginia | 26506-9180 | United States |
| Investigational Site Number 840038 | Milwaukee | Wisconsin | 53215 | United States |
| Investigational Site Number 840112 | Milwaukee | Wisconsin | United States |
| Investigational Site Number 840076 | Neenah | Wisconsin | 54956 | United States |
| Investigational Site Number 040-001 | Linz | Austria |
| Investigational Site Number 040-002 | Vienna | Austria |
| Investigational Site Number 056006 | Brasschaat | 2930 | Belgium |
| Investigational Site Number 056001 | Brussels | 1200 | Belgium |
| Investigational Site Number 056003 | Edegem | 2650 | Belgium |
| Investigational Site Number 056002 | Kortrijk | 8500 | Belgium |
| Investigational Site Number 056007 | Leuven | 3000 | Belgium |
| Investigational Site Number 056008 | Liège | 4000 | Belgium |
| Investigational Site Number 056009 | Liège | 4000 | Belgium |
| Investigational Site Number 056005 | Melsbroek | 1820 | Belgium |
| Investigational Site Number 124006 | Cambridge | N1R7L6 | Canada |
| Investigational Site Number 124007 | St. John's | E2L 4L2 | Canada |
| Investigational Site Number 152003 | Concepción | Chile |
| Investigational Site Number 152001 | Santiago | Chile |
| Investigational Site Number 152005 | Santiago | Chile |
| Investigational Site Number 246004 | Hämeenlinna | 13530 | Finland |
| Investigational Site Number 246005 | Kuopio | Finland |
| Investigational Site Number 246006 | Oulu | 90220 | Finland |
| Investigational Site Number 246001 | Turku | 20520 | Finland |
| Investigational Site Number 246003 | Turku | 20520 | Finland |
| Investigational Site Number 250002 | Agen | 47923 | France |
| Investigational Site Number 250003 | Aix-en-Provence | 13616 | France |
| Investigational Site Number 250004 | Albi | 81000 | France |
| Investigational Site Number 250005 | Amiens | 80054 | France |
| Investigational Site Number 250006 | Bayonne | 64109 | France |
| Investigational Site Number 250007 | Bordeaux | 33000 | France |
| Investigational Site Number 250008 | Caen | 14000 | France |
| Investigational Site Number 250009 | Cahors | 46005 | France |
| Investigational Site Number 250011 | Chambéry | 73000 | France |
| Investigational Site Number 250012 | Colmar | 68024 | France |
| Investigational Site Number 250001 | Dijon | 21000 | France |
| Investigational Site Number 250015 | Grenoble | 38043 | France |
| Investigational Site Number 250017 | Le Mans | 72037 | France |
| Investigational Site Number 250018 | Lille | 59037 | France |
| Investigational Site Number 250019 | Limoges | 87000 | France |
| Investigational Site Number 250020 | Lyon | 69275 | France |
| Investigational Site Number 250021 | Marseille | 13008 | France |
| Investigational Site Number 250022 | Metz-Tessy | 74370 | France |
| Investigational Site Number 250023 | Montbéliard | 25200 | France |
| Investigational Site Number 250024 | Montpellier | 34295 | France |
| Investigational Site Number 250025 | Mulhouse | 68100 | France |
| Investigational Site Number 250026 | Nancy | France |
| Investigational Site Number 250027 | Nantes | 44093 | France |
| Investigational Site Number 250028 | Nîmes | 30029 | France |
| Investigational Site Number 250016 | Paris | 75013 | France |
| Investigational Site Number 250029 | Paris | 75970 | France |
| Investigational Site Number 250043 | Pau | 64000 | France |
| Investigational Site Number 250031 | Quimper | 29000 | France |
| Investigational Site Number 250032 | Reims | 51100 | France |
| Investigational Site Number 250033 | Rouen | 76000 | France |
| Investigational Site Number 250030 | Saint-Germain-en-Laye | 78100 | France |
| Investigational Site Number 250035 | Strasbourg | 67091 | France |
| Investigational Site Number 250037 | Toulouse | 31200 | France |
| Investigational Site Number 250038 | Tours | 37044 | France |
| Investigational Site Number 250039 | Valence | 26953 | France |
| Investigational Site Number 250040 | Valenciennes | 59322 | France |
| Investigational Site Number 250013 | Vichy | 03201 | France |
| Investigational Site Number 276001 | Bergisch Gladbach | 51429 | Germany |
| Investigational Site Number 276003 | Berlin | 12099 | Germany |
| Investigational Site Number 276004 | Freiburg im Breisgau | 79098 | Germany |
| Investigational Site Number 300002 | Athens | 11521 | Greece |
| Investigational Site Number 300001 | Athens | 11525 | Greece |
| Investigational Site Number 300005 | Larissa | 41110 | Greece |
| Investigational Site Number 300004 | Thessaloniki | 546 36 | Greece |
| Investigational Site Number 380008 | Ancona | 60126 | Italy |
| Investigational Site Number 380009 | Bari | 70124 | Italy |
| Investigational Site Number 380002 | Gallarate (VA) | 21013 | Italy |
| Investigational Site Number 380001 | Milan | 20132 | Italy |
| Investigational Site Number 380004 | Milan | 20133 | Italy |
| Investigational Site Number 380006 | Naples | 80138 | Italy |
| Investigational Site Number 380005 | Orbassano (TO) | 10043 | Italy |
| Investigational Site Number 578002 | Bergen | 5021 | Norway |
| Investigational Site Number 578003 | Namsos | 7800 | Norway |
| Investigational Site Number 578001 | Oslo | 0407 | Norway |
| Investigational Site Number 724004 | A Coruña | 15006 | Spain |
| Investigational Site Number 724002 | Barcelona | 08035 | Spain |
| Investigational Site Number 724010 | Córdoba | 14004 | Spain |
| Investigational Site Number 724008 | Donostia / San Sebastian | 20014 | Spain |
| Investigational Site Number 724001 | El Palmar (murcia) | 30120 | Spain |
| Investigational Site Number 724006 | Santiago de Compostela | 15706 | Spain |
| Investigational Site Number 724007 | Valencia | 46009 | Spain |
| Investigational Site Number 724005 | Valladolid | 47011 | Spain |
| Investigational Site Number 752001 | Karlstad | 65185 | Sweden |
| Investigational Site Number 752003 | Kungsbacka | 43480 | Sweden |
| Investigational Site Number 752002 | Motala | 59185 | Sweden |
| Investigational Site Number 826-005 | Birmingham | B152TH | United Kingdom |
| Investigational Site Number 826-003 | Brighton | BN25BE | United Kingdom |
| Investigational Site Number 826-007 | Glasgow | G116NT | United Kingdom |
| Investigational Site Number 826-008 | Leeds | LS13EX | United Kingdom |
| Investigational Site Number 826-010 | Leicester | LE54PW | United Kingdom |
| Investigational Site Number 826-009 | London | SW170QT | United Kingdom |
| Investigational Site Number 826-001 | Norwich | nr34dg | United Kingdom |
| Investigational Site Number 826-006 | Romford | RM70AG | United Kingdom |
| Investigational Site Number 826-004 | Salford | M68HD | United Kingdom |
| Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included all treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriflunomide | Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48 | 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. | Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Week 48 |
|
|
| |||||||||||||||||||||||||
| Secondary | Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48 | 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 . | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Week 4 in TSQM Scores in Naïve Participants to Week 48 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Week 4, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48 | 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. | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48 | 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. | Analysis was performed on Efficacy population. Here, 'n' signifies number of participants with available data at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized Treated Relapse Rate | 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. | Analysis was performed on Efficacy population. | Posted | Number | relapses per patient-year | Baseline up to end of treatment (up to Week 48) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48 | 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. | Analysis was performed on Efficacy population. | Posted | Number | 95% Confidence Interval | percent probability of treated relapse | Baseline up to end of treatment (up to Week 48) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48 | 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. | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Overview of Adverse Events (AEs) | 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. | Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP. | Posted | Number | percentage of participants | 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 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period | 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. | Analysis was performed on Safety population. | Posted | Number | percentage of participants | Baseline up to end of treatment (up to Week 48) |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Teriflunomide Treatment Exposure | 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). | Analysis was performed on Safety population. | Posted | Mean | Standard Deviation | Days | Baseline up to end of treatment (up to Week 48) |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48 | 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. | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Stern Leisure Activity Scale at Week 48 | 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. | Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 |
|
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teriflunomide | Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks. | 127 | 1,000 | 498 | 1,000 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Blindness Unilateral | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal Artery Thrombosis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal Hernia Obstructive | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis Microscopic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Myelitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal Candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic Abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Perichondritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium Test Positive | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Fibrin D Dimer Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Non-Small Cell Lung Cancer Stage Iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral Sarcoidosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervicobrachial Syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Medication Overuse Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple Sclerosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neuromyelitis Optica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Toxic Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Trigeminal Neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Uhthoff's Phenomenon | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Acute Psychosis | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Adjustment Disorder With Depressed Mood | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertonic Bladder | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Female Genital Tract Fistula | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute Interstitial Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthmatic Crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lung Cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominoplasty | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Essential Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527525 | teriflunomide |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|