Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HMR1726D/2005 | Other Identifier | HMR | |
| 2007-003997-24 | EudraCT Number |
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The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with multiple sclerosis [MS] with relapses.
Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging [MRI] parameters.
This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
The duration of the extension study per participants was 40 weeks broken down as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + IFN-β | Placebo Comparator | Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
|
| Teriflunomide 7 mg + IFN-β | Experimental | Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
|
| Teriflunomide 14 mg + IFN-β | Experimental | Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] for 24 additional weeks |
|
| Placebo + GA | Placebo Comparator | Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
|
| Teriflunomide 7 mg + GA | Experimental | Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriflunomide | Drug | Film-coated tablet Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overview of Adverse Events [AE] | AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. | from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
| Overview of AE With Potential Risk of Occurence | AE with potential risk of occurrence were defined as follows:
| from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
| Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows:
| from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate [ARR]: Poisson Regression Estimates | ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores. To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as "offset" variable and:
|
Not provided
Inclusion Criteria:
PDY6045 or PDY6046 participant who:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22622860 | Result | Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23. | |
| 28607708 |
Not provided
Not provided
An Interactive Voice Response System was used to allocate kits containing the same treatment as in the initial study.
Analysis included all participants randomized in the initial studies and all data collected from randomization according to intent-to-treat principal.
107 and 110 participants who successfully completed 24-week visit in, respectively, PDY6045 and PDY6046 studies, were offered to continue their treatment in this extension study.
After signature of the informed consent and confirmation of selection criteria, 86 and 96 participants entered the extension study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + IFN-β | Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] |
| FG001 | Teriflunomide 7 mg + IFN-β | Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment (PDY6045 or PDY6046) |
|
Not provided
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| Teriflunomide 14 mg + GA | Experimental | Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 additional weeks |
|
|
| Placebo (for teriflunomide) | Drug | Film-coated tablet Oral administration |
|
| Interferon-β [IFN-β] | Drug | Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection |
|
|
| Glatiramer Acetate [GA] | Drug | Solution in prefilled syringe for subcutaneous injection |
|
|
| 48 weeks |
| Overview of 12-week Sustained Disability Progression | 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression. | 48 weeks |
| Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation. Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t. | 48 weeks |
| Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) | Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis. Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:
| baseline (before randomization in PDY6045 or PDY6046) and 48 weeks |
| Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) | Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as "offset" variable and:
| 48 weeks |
| Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan | Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. | 48 weeks |
| Vienna |
| Austria |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Guildford | United Kingdom |
| Derived |
| Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec. |
| FG002 | Teriflunomide 14 mg + IFN-β | Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| FG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| FG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| FG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
| COMPLETED |
|
| NOT COMPLETED |
|
| Extension Treatment |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + IFN-β | Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] |
| BG001 | Teriflunomide 7 mg + IFN-β | Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] |
| BG002 | Teriflunomide 14 mg + IFN-β | Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| BG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| BG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| BG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline characteristics before randomization in the initial study (PDY6045 or PDY6046) | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Europe: Austria, Germany, Italy, Spain and United Kingdom North America: Canada and United States | Number | 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 | Overview of Adverse Events [AE] | AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. | All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | participants | from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Annualized Relapse Rate [ARR]: Poisson Regression Estimates | ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores. To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as "offset" variable and:
| All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | 95% Confidence Interval | relapses per year | 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Overview of AE With Potential Risk of Occurence | AE with potential risk of occurrence were defined as follows:
| All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | participants | from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overview of 12-week Sustained Disability Progression | 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression. | All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | participants | 48 weeks |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints | Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation. Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t. | All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | 95% Confidence Interval | percent probability | 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) | Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis. Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:
| All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Least Squares Mean | Standard Error | mililiters (mL) | baseline (before randomization in PDY6045 or PDY6046) and 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates) | Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as "offset" variable and:
| All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | 95% Confidence Interval | lesions per scan | 48 weeks |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows:
| All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | participants | from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan | Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study. | All randomized and treated participants; Participants were included in the treatment group according to the drug actually received. | Posted | Number | mililiters per scan | 48 weeks |
|
All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent up to the last visit.
The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured first (64 weeks max).
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 | Placebo + IFN-β | Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β] | 2 | 41 | 28 | 41 | ||
| EG001 | Teriflunomide 7 mg + IFN-β | Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β] | 4 | 37 | 33 | 37 | ||
| EG002 | Teriflunomide 14 mg + IFN-β | Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] | 1 | 38 | 32 | 38 | ||
| EG003 | Placebo + GA | Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] | 6 | 40 | 34 | 40 | ||
| EG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] | 5 | 42 | 30 | 42 | ||
| EG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] | 2 | 41 | 34 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.
To protect by property right the sponsor can postpone the publication of any information, for a period not exceeding 18 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi-aventis | Contact_US@sanofi-aventis.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 |
| D000068556 | Interferon beta-1a |
| D000068576 | Interferon beta-1b |
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Progressive disease |
|
| Participant did not wish to continue |
|
| Other than above |
|
| >=38 years |
|
| Male |
|
| North America |
|
| - serious AE |
|
| - AE leading to death |
|
| - AE leading to study drug discontinuation |
|
| OG002 |
| Teriflunomide 14 mg + IFN-β |
Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| OG003 | Placebo + GA | Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] |
|
|
| Placebo + GA |
Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| OG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
| OG002 |
| Teriflunomide 14 mg + IFN-β |
Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| OG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β] |
| OG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
| OG003 | Placebo + GA | Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] |
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|
| OG004 | Teriflunomide 7 mg + GA | Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] |
| OG005 | Teriflunomide 14 mg + GA | Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] |
|
|