drugset / Trial / NCT01500551
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
NaSingle-groupOpen-labelTreatment
Summary
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
Timeline
- Start
- 2013-03-18
- Primary completion
- 2025-02-12
- Completion
- 2025-02-12
Publications
- Brunner HI, Akikusa JD, Al-Abadi E, Bohnsack JF, Boteanu AL, Chedeville G, Cuttica R, De La Pena W, Jung L, Kasapcopur O, Kobusinska K, Schulert GS, Neiva C, Rivas-Chacon R, Rizo Rodriguez JC, Vazquez-Del Mercado M, Wagner-Weiner L, Weiss JE, Wouters C, Posner H, Wouters A, Chang C, White C, Kanik K, Liu S, Martini A, Lovell DJ, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and Pediatric Rheumatology Collaborative Study Group (PRCSG). Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study. Ann Rheum Dis. 2024 Oct 21;83(11):1561-1571. doi: 10.1136/ard-2023-225094.
- 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.
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 |