Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis (TERIKIDS)
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ClinicalTrials.gov Identifier: NCT02201108 |
Recruitment Status :
Active, not recruiting
First Posted : July 25, 2014
Results First Posted : November 30, 2020
Last Update Posted : November 30, 2020
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Multiple Sclerosis |
Interventions |
Drug: Teriflunomide Drug: Placebo |
Enrollment | 166 |
Participant Flow
Recruitment Details | Study was conducted at 57 active centers in 21 countries. A total of 185 participants were screened between 16 July 2014 and 27 December 2017, of which 166 participants were enrolled and randomized. A total of 19 participants failed screening mainly due to meeting exclusion criteria. |
Pre-assignment Details | Participants were randomly assigned to receive either teriflunomide or placebo in a 2:1 ratio (109 teriflunomide and 57 placebo) via Interactive Voice Response System. Randomization was stratified by the country and participant's pubertal status. Data reported based on the primary completion date of 25 October 2019. |
Arm/Group Title | Placebo | Teriflunomide |
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Participants received Placebo matching to teriflunomide tablet orally once daily (QD) for 96 weeks. | Participants received 1 Teriflunomide tablet, 3.5 milligram (mg) (in case of body weight [BW] up to 40 kilogram [kg]) or 7 mg (in case of BW greater than[>] 40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted pharmacokinetic (PK) parameters, teriflunomide was administered in following manner up to 96 weeks:if predicted PK parameters less than or equal to (<=) 95th percentile of adult range after 7 mg QD:1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW>40 kg); or if predicted PK parameters>95th percentile of adult range:1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW>40 kg). The adult range (5th-95th percentile) of predicted steady state PK parameters for 7 mg dose was defined as maximum concentration observed (Cmax) ranging from 8.03 to 49.10 microgram per milliliter (mcg/mL) and area under the curve from time 0 hour to 24 hours (AUC0-24) ranging from 184 to 1160 microgram*hour per milliliter (mcg*h/mL). |
Period Title: Overall Study | ||
Started [1] | 57 | 109 |
On-going Participants | 0 | 58 |
Completed | 53 | 102 |
Not Completed | 4 | 7 |
Reason Not Completed | ||
Adverse Event | 0 | 6 |
Lack of Efficacy | 2 | 1 |
Withdrawal by Subject | 2 | 0 |
[1]
Randomized and treated participants.
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Baseline Characteristics
Arm/Group Title | Placebo | Teriflunomide | Total | |
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Participants received Placebo matching to teriflunomide tablet orally QD for 96 weeks. | Participants received 1 Teriflunomide tablet, 3.5 mg (in case of BW up to 40 kg) or 7 mg (in case of BW >40 kg) orally QD for 8 weeks. After 8 weeks, based on participant's predicted PK parameters, teriflunomide was administered in following manner up to 96 weeks: if predicted PK parameters <= 95th percentile of adult range after 7 mg QD: 1 tablet of 7 mg daily (for BW up to 40 kg) or 1 tablet of 14 mg daily (for BW >40 kg); or if predicted PK parameters >95th percentile of adult range: 1 tablet of 3.5 mg daily (for BW up to 40 kg) or 1 tablet of 7 mg daily (for BW >40 kg). The adult range (5th - 95th percentile) of predicted steady state PK parameters for a 7 mg dose was defined as Cmax ranging from 8.03 to 49.10 mcg/mL and AUC0-24 ranging from 184 to 1160 mcg*h/mL. | Total of all reporting groups | |
Overall Number of Baseline Participants | 57 | 109 | 166 | |
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Analysis was performed on all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 57 participants | 109 participants | 166 participants | |
14.7 (2.1) | 14.6 (2.0) | 14.6 (2.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 57 participants | 109 participants | 166 participants | |
Female |
39 68.4%
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72 66.1%
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111 66.9%
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Male |
18 31.6%
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37 33.9%
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55 33.1%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 57 participants | 109 participants | 166 participants |
Caucasian/White |
42 73.7%
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75 68.8%
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117 70.5%
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Black |
1 1.8%
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4 3.7%
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5 3.0%
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Asian/Oriental |
12 21.1%
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25 22.9%
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37 22.3%
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Other |
2 3.5%
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5 4.6%
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7 4.2%
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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.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Genzyme, a Sanofi Company |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi ( Genzyme, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT02201108 |
Other Study ID Numbers: |
EFC11759 2011-005249-12 ( EudraCT Number ) U1111-1124-0983 ( Other Identifier: WHO Universal Trial Reference Number (UTRN) ) |
First Submitted: | July 17, 2014 |
First Posted: | July 25, 2014 |
Results First Submitted: | October 20, 2020 |
Results First Posted: | November 30, 2020 |
Last Update Posted: | November 30, 2020 |