Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Juvenile Idiopathic Arthritis
Interventions
DRUG

CP-690,550

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

DRUG

CP-690,550

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

DRUG

CP-690,550

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

Trial Locations (10)

22081

Hamburger Zentrum fuer Kinder-und Jugendrheumatologie SchoenKlinik Hamburg Eilbek, Hamburg

24576

PRI - Pediatric Rheumatology Research Institute GmbH, Bad Bramstedt

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

53757

Asklepios Klinik Sankt Augustin Gmbh, Sankt Augustin

55454

Explorer Clinic, University of Minnesota Children's Hospital, Minneapolis

55455

Clinical and Translational Science Institute Masonic Clinical Research Unit (Administration Only), Minneapolis

97227

Randall Children's Hospital at Legacy Emanuel, Portland

31-503

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie, Krakow

91-738

Klinika Kardiologii i Reumatologii Dzieciecej, Lodz

921 12

Narodny ustav reumatickych chorob, Piešťany

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01513902 - Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA) | Biotech Hunter | Biotech Hunter