Conditions: Juvenile Idiopathic Arthritis
Keywords: Arthritis Pediatric Tofacitinib JIA
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief 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).

Detailed description:
This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice daily for 5 days \[except Day 5 when only morning dose will be given\]) study in pediatric subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1 month of the completion of the Screening Visit. The study will consist of three cohorts based on the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than 12 years and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric subjects with JIA will participate in the study ensuring a total number of at least 24 pediatric evaluable subjects completing the PK period.

Arms:
arm 1: Ages 12 to less than 18 arm 2: Ages 6 to less than 12 arm 3: Ages 2 to less than 6

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5 intervention 2: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5 intervention 3: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing \<30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5

Protocol document: