Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)
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ClinicalTrials.gov Identifier: NCT00622700 |
Recruitment Status :
Completed
First Posted : February 25, 2008
Results First Posted : December 19, 2014
Last Update Posted : March 13, 2017
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Multiple Sclerosis |
Interventions |
Drug: Teriflunomide Drug: Placebo |
Enrollment | 618 |
Participant Flow
Recruitment Details | A total of 846 participants were screened, of which 618 randomized in core treatment period. Out of 618, 423 entered in extension treatment period. End date of core treatment period was 17 December 2012 (maximum treatment duration: 120 weeks). End date of extension treatment period was 05 February 2016 (maximum treatment duration: 283 weeks). |
Pre-assignment Details | Participants were randomized in 1:1:1 ratio to teriflunomide 7 mg,14 mg or placebo in core treatment period. Those completing core period, given opportunity to enter long-term extension period (participants originally given placebo re-randomized [1:1]to teriflunomide 7 mg/14 mg; those originally given 7 mg,14 mg continued with the same fixed dose). |
Arm/Group Title | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg | Placebo/ Teriflunomide 7 mg | Teriflunomide 7 mg/7 mg | Placebo/Teriflunomide 14 mg | Teriflunomide 14 mg/14 mg |
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Core treatment period: Placebo matched to teriflunomide tablet once daily orally. | Core treatment period: Teriflunomide 7 mg tablet once daily orally. | Core treatment period: Teriflunomide 14 mg tablet once daily orally. |
Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally. |
Core treatment period: Teriflunomide 7 mg tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally. |
Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally. |
Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally. |
Period Title: Core Treatment Period | |||||||
Started | 197 | 205 | 216 | 0 | 0 | 0 | 0 |
Treated | 197 | 203 | 214 | 0 | 0 | 0 | 0 |
Completed | 141 | 150 | 163 | 0 | 0 | 0 | 0 |
Not Completed | 56 | 55 | 53 | 0 | 0 | 0 | 0 |
Reason Not Completed | |||||||
Randomized but Not Treated | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
Adverse Event | 18 | 25 | 18 | 0 | 0 | 0 | 0 |
Lack of Efficacy | 19 | 6 | 12 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Progressive Disease | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 12 | 18 | 15 | 0 | 0 | 0 | 0 |
Other than specified above | 2 | 2 | 5 | 0 | 0 | 0 | 0 |
Period Title: Extension Treatment Period | |||||||
Started | 0 [1] | 0 | 0 | 64 [2] | 142 [3] | 67 [2] | 150 [4] |
Completed | 0 | 0 | 0 | 43 | 103 | 50 | 120 |
Not Completed | 0 | 0 | 0 | 21 | 39 | 17 | 30 |
Reason Not Completed | |||||||
Adverse Event | 0 | 0 | 0 | 5 | 9 | 6 | 8 |
Lack of Efficacy | 0 | 0 | 0 | 2 | 8 | 1 | 9 |
Protocol Violation | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Progressive Disease | 0 | 0 | 0 | 1 | 2 | 0 | 2 |
Withdrawal by Subject | 0 | 0 | 0 | 11 | 16 | 6 | 10 |
Missing | 0 | 0 | 0 | 2 | 3 | 1 | 0 |
Other than specified above | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
[1]
Participants were re-randomized in a 1:1 ratio to either teriflunomide 7 mg or 14 mg treatment arm.
[2]
10 participants completed core treatment period but did not enter in extension treatment period.
[3]
8 participants completed core treatment period but did not enter in extension treatment period.
[4]
13 participants completed core treatment period but did not enter in extension treatment period.
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Baseline Characteristics
Arm/Group Title | Placebo | Teriflunomide 7 mg | Teriflunomide 14 mg | Total | |
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Placebo matched to teriflunomide tablet once daily orally. | Teriflunomide 7 mg tablet once daily orally. | Teriflunomide 14 mg tablet once daily orally. | Total of all reporting groups | |
Overall Number of Baseline Participants | 197 | 205 | 216 | 618 | |
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Randomized population: all randomized participants according to the treatment group to which they were assigned in the core treatment period.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 197 participants | 205 participants | 216 participants | 618 participants | |
32.0 (8.4) | 31.6 (9.0) | 32.8 (8.1) | 32.7 (8.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 197 participants | 205 participants | 216 participants | 618 participants | |
Female |
135 68.5%
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130 63.4%
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154 71.3%
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419 67.8%
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Male |
62 31.5%
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75 36.6%
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62 28.7%
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199 32.2%
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Region
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 197 participants | 205 participants | 216 participants | 618 participants |
Eastern Europe | 94 | 96 | 101 | 291 | |
Western Europe | 76 | 74 | 74 | 224 | |
Americas and Australia | 27 | 35 | 41 | 103 | |
Expanded Disability Status Scale (EDSS) Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 197 participants | 205 participants | 216 participants | 618 participants | |
1.71 (1.00) | 1.50 (1.02) | 1.80 (0.97) | 1.67 (1.00) | ||
[1]
Measure Description: EDSS is an ordinal scale in half-point increments that qualifies disability in participants 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).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
EMail: | Contact-us@sanofi.com |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00622700 |
Other Study ID Numbers: |
EFC6260 HMR1726D-3005 ( Other Identifier: HMR ) 2006-001152-12 ( EudraCT Number ) |
First Submitted: | February 14, 2008 |
First Posted: | February 25, 2008 |
Results First Submitted: | November 7, 2014 |
Results First Posted: | December 19, 2014 |
Last Update Posted: | March 13, 2017 |