Phase 3
Completed N=166
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Source: ClinicalTrials.gov NCT02201108 ↗Enrolled (actual)
166
Serious AEs
15.9%
Results posted
Nov 2020
Primary outcomePrimary: Time to First Confirmed Clinical Relapse — 39.14; 75.29 weeks — p=0.2949
◆ Published Evidence
Established
81citations · ~16 / year
Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial.
Summary
Primary Objective:
To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS).
Secondary Objective:
* To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.
* To evaluate the safety and tolerability of teriflunomide in comparison to placebo.
* To evaluate the pharmacokinetics (PK) of teriflunomide.
Linked Publications (3)
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Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial.
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Plasma neurofilament light chain in children with relapsing MS receiving teriflunomide or placebo: A post hoc analysis of the randomized TERIKIDS trial.
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Teriflunomide in pediatric patients with relapsing multiple sclerosis: Open-label extension of TERIKIDS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Confirmed Clinical Relapse |
39.14; 75.29 | 0.2949 |
| SECONDARY Probability of Participants Who Were Clinical Relapse Free at Weeks 24, 48, 72, 96, 120, 144, 168 and 192 |
0.750; 0.820; 0.596; 0.700; 0.519; 0.630 | — |
| SECONDARY Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan |
11.087; 5.664 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Number of T1 Gadolinium (Gd)-Enhancing T1 Lesions Per MRI Scan |
2.686; 1.532 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T2 Lesions at Weeks 24, 36, 48, 72, 96, 144 and 192 |
3.0; 0.5; 4.6; 4.4; 0.5; -0.2 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Change From Baseline in Volume of T1 Hypointense Lesions |
0.3; 0.0; 0.8; 0.2; 0.2; 0.4 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Number of New T1 Hypointense Lesions Per MRI Scan |
1561; 1910 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Percentage of Participants Free of New or Enlarged MRI T2-Lesions |
86.5; 86.0; 32.7; 25.0; 15.4; 17.0 | — |
| SECONDARY Brain Magnetic Resonance Imaging Assessment: Percent Change From Baseline in Brain Volume at Weeks 24, 36, 48, 72, 96, 144 and 192 |
-0.3; -0.2; -0.7; -0.4; -0.6; -0.5 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Total Number of Correct Substitutions Measured by Symbol Digit Modalities Test (SDMT) at Weeks 24, 48, 72, 96, 120, 144, 168 and 192 |
5.1; 4.6; 7.3; 5.7; 6.4; 5.6 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Number of Completed Items Measured by Symbol Digit Modalities Test at Weeks 24, 48, 72, 96, 120, 144, 168 and 192 |
3.8; 3.6; 6.3; 4.7; 5.1; 4.5 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Brief Visuospatial Memory Test-Revised (BVMT-R) Scores at Weeks 96 and 192 |
23.8; 24.8; -0.8; 1.6; 1.0; 1.2 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Trail Making Test- Part A (TMT-A) Test Scores (in Seconds) at Week 96 and 192 |
43.4; 47.1; 8.4; -3.1; 6.3; -6.6 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Trail Making Test B (TMT-B) Test Scores (in Seconds) at Weeks 96 and 192 |
113.8; 115.0; -19.8; -29.5; -37.0; -18.8 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Beery Visual-motor Integration (BVMI) Scores at Weeks 96 and 192 |
26.1; 25.9; 0.6; -0.4; 0.1; 0.4 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Vocabulary Total Raw Scores at Weeks 96 and 192 |
39.0; 34.3; 5.0; 4.0; 3.0; 5.0 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Letter Fluency Total Correct Raw Score at Weeks 96 and 192 |
32.5; 21.0; -3.0; 4.0; 5.0; -6.5 | — |
| SECONDARY Cognitive Assessment: Change From Baseline in Delis-Kaplan Executive Function System Category Fluency Total Correct Raw Score at Weeks 96 and 192 |
28.0; 27.5; 6.0; 5.0; -2.0; -13.5 | — |
| SECONDARY Cognitive Assessment - Selective Reminding Test (SRT): Change From Baseline in Total Number of Words on Delayed Recall at Weeks 96 and 192 |
3.5; 10.0; 1.0; -0.5; 0.0; 0.0 | — |
| SECONDARY DB: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide |
53.1; 67.8 | — |
| SECONDARY OL: Time to First Confirmed Clinical Relapse |
95.86; 96.00 | — |
| SECONDARY OL: Pharmacokinetics: Steady-state Trough Concentration (Ctrough) of Teriflunomide |
45.8; 50.4; 33.7; 63.6 | — |
Eligibility Criteria
- Participants with relapsing MS were eligible. Participants who met the criteria of MS based on McDonald criteria 2010 and International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, version of 2012 and had:
- at least one relapse (or attack) in the 12 months preceding screening or,
- at least two relapses (or attack) in the 24 months preceding screening.
- Less than 18 years of age and greater than or equal to (>=) 10 years of age at randomization. Specific for the Russian Federation from 18 December 2014 to 26 July 2016, less than or equal to 17 years of age and >= 13 years of age at randomization.
- Signed informed consent/assent obtained from participant and participant's legal representative (parents or guardians) according to local regulations.
Exclusion criteria
- Expanded disability status scale score greater than 5.5 at screening or randomization visits.
- Relapse within 30 days prior to randomization.
- Treated with:
- glatiramer acetate, interferons, or dimethyl fumarate within 1 month prior to randomization.
- fingolimod, or intravenous immunoglobulins within 3 months prior to randomization.
- natalizumab, other immunosuppressant or immunomodulatory agents such as cyclophosphamide, azathioprine, cyclosporine, methotrexate, mycophenolate, within 6 months prior to randomization.
- cladribine or mitoxantrone within 2 years prior to randomization.
- Treated with alemtuzumab at any time.
- History of human immunodeficiency virus infection.
- Contraindication for MRI.
- Pregnant or breast-feeding females or those who plan to become pregnant during the study.
- Female participants of child-bearing potential not using highly effective contraceptive method (contraception in both female and male was required).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02201108) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.