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The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.
Secondary objectives were:
The total duration of the study period per participants was 46 weeks comprising 3 periods:
Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (for teriflunomide),
|
|
| Teriflunomide 7 mg | Experimental | Teriflunomide 7 mg:
|
|
| Teriflunomide 14 mg | Experimental | Teriflunomide 14 mg:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriflunomide | Drug | film-coated tablet oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI assessment: number of unique active lesions per scan (T2/proton density and gadolinium-enhanced T1 scan analysis) | The number of unique active lesions per scan was calculated by dividing the sum of unique newly active lesions and unique persistently active lesions observed on treatment by the number of scans performed on treatment. Unique newly active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan but not in the previous scan and, that had not been classified as unique newly active in any previous scan. Unique persistently active lesions were all unique T1 and T2 lesions identified, one or more times, in a scan and also in the previous scan. | 36 weeks |
| 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 up to 6 weeks after last intake or entry in the extension study, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| MRI assessment: number of T1-enhancing lesions per scan | T1-enhancing lesions included:
| 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Director | Clinical Science & Operation - sanofi-aventis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canada | Toronto | Ontario | Canada | |||
| sanofi-aventis France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16567708 | Result | O'Connor PW, Li D, Freedman MS, Bar-Or A, Rice GP, Confavreux C, Paty DW, Stewart JA, Scheyer R; Teriflunomide Multiple Sclerosis Trial Group; University of British Columbia MS/MRI Research Group. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006 Mar 28;66(6):894-900. doi: 10.1212/01.wnl.0000203121.04509.31. | |
| 33023488 |
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| 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 |
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| ID | Term |
|---|---|
| C527525 | teriflunomide |
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| Placebo (placebo for teriflunomide) | Drug | film-coated tablet oral administration |
|
| MRI assessment: number of T2-lesions per scan |
T2-lesions included:
|
| 36 weeks |
| MRI assessment: Number of participants with no new lesions | New lesions included new T2 lesions, new enhanced T1 lesions and unique newly active lesions. | 36 weeks |
| MRI assessment: Change from baseline in T2 burden of disease | T2 burden of disease was defined as the total volume of all T2 lesions. | 36 weeks |
| Number of participants with progression on Expanded Disability Status Scale [EDSS] | EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Progression was defined as an increase in EDSS score by at least 1-point when baseline EDSS score ≤5.5 or an increase in EDSS score by at least 0.5-point in when baseline EDSS score >5.5. | 36 weeks |
| Number of participants with MS relapse confirmed by Scripps Neurological Rating Scale [NRS] and EDSS scores. | A relapse was defined as the appearance, reappearance or worsening of a symptom attributable to MS. The change had to persist for at least 48 hours in the absence of fever and be preceded by stability or improvement for at least 30 days. Relapses were to be confirmed by Scripps NRS and EDSS scores. NRS is a scale that qualifies the degree of impairment from a neurological exam of the following systems: mentation and mood, cranial nerves, motor nerves, deep tendon reflexes, sensory nerves, cerebellum, gait/trunk/balance, bladder/bowel/sexual dysfunction. NRS score ranges from 0 to 100 (lower degree of impairment). | 36 weeks |
| Lyon |
| France |
| Derived |
| Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |