Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
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.
Timeline
- Start
- 2014-07-16
- Primary completion
- 2019-10-25
- Completion
- 2024-07-29
Outcome
Missed primary endpoint
registry analysis (superiority test); Double-Blind Treatment Period: Placebo vs Double-Blind Treatment Period: Teriflunomide; p = 0.2949 NCT02201108 ↗
paper there was no difference in time to first confirmed clinical relapse with teriflunomide compared with placebo PMID 34800398 ↗
Publications
- Chitnis T, Banwell B, Kappos L, Arnold DL, Gucuyener K, Deiva K, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M. Teriflunomide in pediatric patients with relapsing multiple sclerosis: Open-label extension of TERIKIDS. Mult Scler. 2024 Jun;30(7):833-842. doi: 10.1177/13524585241242050. Epub 2024 Apr 15.
- Kuhle J, Chitnis T, Banwell B, Tardieu M, Arnold DL, Rawlings AM, Geertsen SS, Lublin AL, Saubadu S, Truffinet P, Kappos L. Plasma neurofilament light chain in children with relapsing MS receiving teriflunomide or placebo: A post hoc analysis of the randomized TERIKIDS trial. Mult Scler. 2023 Mar;29(3):385-394. doi: 10.1177/13524585221144742. Epub 2023 Jan 12.
- Chitnis T, Banwell B, Kappos L, Arnold DL, Gucuyener K, Deiva K, Skripchenko N, Cui LY, Saubadu S, Hu W, Benamor M, Le-Halpere A, Truffinet P, Tardieu M; TERIKIDS Investigators. Safety and efficacy of teriflunomide in paediatric multiple sclerosis (TERIKIDS): a multicentre, double-blind, phase 3, randomised, placebo-controlled trial. Lancet Neurol. 2021 Dec;20(12):1001-1011. doi: 10.1016/S1474-4422(21)00364-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teriflunomide | Small molecule | 3.5 mg | Oral |
| Subject | Teriflunomide | Small molecule | 7 mg | Oral |
| Subject | Teriflunomide | Small molecule | 14 mg | Oral |