drugset / Trial / NCT02592434
Efficacy Study Of Tofacitinib In Pediatric JIA Population
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.
Timeline
- Start
- 2016-06-10
- Primary completion
- 2019-05-16
- Completion
- 2019-05-16
Publications
- Consolaro A, Ruperto N, Lovell DJ, Synoverska O, Abud-Mendoza C, Spindler A, Vyzhga Y, Alexeeva E, Chaitow J, Chiraseveenuprapund P, Lazariciu I, Stockert L, Cadatal MJ, Diehl A, Brunner HI; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Clinically Inactive Disease and Remission in Patients With Juvenile Idiopathic Arthritis Receiving Tofacitinib: Post Hoc Analysis of a Phase III Trial. J Rheumatol. 2025 Sep 1;52(9):919-926. doi: 10.3899/jrheum.2024-0536.
- Chang C, Vong C, Wang X, Hazra A, Diehl A, Nicholas T, Mukherjee A. Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis. CPT Pharmacometrics Syst Pharmacol. 2024 Apr;13(4):599-611. doi: 10.1002/psp4.13104. Epub 2024 Jan 31.
- Ruperto N, Brunner HI, Synoverska O, Ting TV, Mendoza CA, Spindler A, Vyzhga Y, Marzan K, Grebenkina L, Tirosh I, Imundo L, Jerath R, Kingsbury DJ, Sozeri B, Vora SS, Prahalad S, Zholobova E, Butbul Aviel Y, Chasnyk V, Lerman M, Nanda K, Schmeling H, Tory H, Uziel Y, Viola DO, Posner HB, Kanik KS, Wouters A, Chang C, Zhang R, Lazariciu I, Hsu MA, Suehiro RM, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial. Lancet. 2021 Nov 27;398(10315):1984-1996. doi: 10.1016/S0140-6736(21)01255-1. Epub 2021 Nov 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tofacitinib | Small molecule | 2 mg | Oral |
| Subject | Tofacitinib | Small molecule | 2.5 mg | Oral |
| Subject | Tofacitinib | Small molecule | 3 mg | Oral |
| Subject | Tofacitinib | Small molecule | 3.5 mg | Oral |
| Subject | Tofacitinib | Small molecule | 4 mg | Oral |
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |