drugset / Trial / NCT01513902
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Non-randomizedParallel-groupOpen-labelBasic science
Summary
Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).
Timeline
- Start
- 2013-03
- Primary completion
- 2015-12
- Completion
- 2015-12
Publications
- 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, Zuber Z, Tzaribachev N, Kingsbury DJ, Foeldvari I, Horneff G, Smolewska E, Vehe RK, Hazra A, Wang R, Mebus CA, Alvey C, Lamba M, Krishnaswami S, Stock TC, Wang M, Suehiro R, Martini A, Lovell DJ; Pediatric Rheumatology International Trials Organization (PRINTO); Pediatric Rheumatology Collaborative Study Group (PRCSG). Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study. Pediatr Rheumatol Online J. 2017 Dec 28;15(1):86. doi: 10.1186/s12969-017-0212-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tofacitinib | Small molecule | 1 mg | Oral |
| Subject | Tofacitinib | Small molecule | 1.5 mg | Oral |
| 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 | 4.5 mg | Oral |
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |