Long-Term Safety Study Of CP-690,550 In Patients With Juvenile Idiopathic Arthritis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-term, Open-label Follow-up Study Of Cp-690,550 For Treatment Of Juvenile Idiopathic Arthritis (Jia)|
- Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development. [ Time Frame: up tp 8 years ] [ Designated as safety issue: Yes ]
- Physician global evaluation of disease activity. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Number of joints with active arthritis. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Number of joints with limitation of motion. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Index of inflammation (C reactive protein [CRP]). [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Juvenile Arthritis Multidimensional Assessment Report (JAMAR). [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Parent's or child evaluation of overall wellbeing (JAMAR Visual Analog Scale [VAS] component). [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Functional ability (JAMAR). [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Health related quality of life (JAMAR). [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- American College of Rheumatology (ACR) pediatric response and flare criteria. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
- Inactive disease status parameters. [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||September 2020|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
All patients will be in tofacitinib treatment group.
Dosing Scheme in Patients Completing Index Study A3921103:
CP 690,550 will be administered orally twice daily 12 hours apart, based on body weight as provided below.
Oral tablets will be used for patients weighing ≥30 kg. Oral solution will be used for patients weighing <30 kg.
Body Weight (Dose in tablet [mg BID] or solution [ml BID]):
5-6kg (1mg or 1 ml); 7-9kg (1.5mg or 1.5ml); 10-12kg (2mg or 2ml); 13-15kg (2.5mg or 2.5 ml); 16-19kg (3mg or 3ml); 20-22kg (3.5mg or 3.5ml); 23-26 (4mg or 4 ml); 27-29 kg (4.5mg or 4.5ml); 30 kg (5mg or 5ml).
Other Name: Tofacitinib, XeljanzDrug: CP-690,550
Dosing Scheme in Patients Completing Index Study A3921104:
Body Weight (dose in tablet [mg BID] or solution [mL BID]):
5 - <7 kg (2 mg or 2 ml); 7 - <10kg (2.5 mg or 2.5 mL); 10 - <15kg (3 mg or 3 mL); 15 - < 20kg (3.5 mg or 3.5 mL); 20 - < 25kg (4 mg or 4 mL); 25 - < 40kg (5 mg or 5 mL);
≥ 40kg (5 mg or 5 ml in AM, 10 mg or 10 mL in PM).
Oral solution will be used for subjects weighing <25 kg. Oral tablets will be used for subjects weighing ≥25 kg.
Other Name: Tofacitinib, Xeljanz
This is a Phase 2/3, long term, open label, follow up study. Patients will have previously participated in qualifying/index JIA studies of CP 690,550. Those who have already completed such participation will participate in a screening visit to determine eligibility. A Baseline Visit will then occur within one month after the Screening Visit. For patients who are still completing participation in a qualifying study of CP 690,550, the Final or End of Study (EOS) Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study.
Up to approximately 290 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.
Pfizer's intent for this study is to make tofacitinib available to patients for as long as it is tolerated and deemed safe and for at least two years after first global marketing approval of tofacitinib for the treatment of JIA, or development of tofacitinib for JIA is discontinued. The total duration of an individual patient's participation may vary depending upon when they entered the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500551
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
|United States, Indiana|
|Riley Hospital for Children at IU Health||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, Minnesota|
|Explorer Clinic, University of Minnesota Children's Hospital||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|United States, Oregon|
|Randall Children's Hospital at Legacy Emanuel||Recruiting|
|Portland, Oregon, United States, 97227|
|United States, Washington|
|Seattle Children's Hospital||Not yet recruiting|
|Seattle, Washington, United States, 98105|
|PRI - Pediatric Rheumatology Research Institute GmbH||Active, not recruiting|
|Bad Bramstedt, Germany, 24576|
|Hamburger Zentrum fuer Kinder - und Jugendrheumatologie||Active, not recruiting|
|Hamburg, Germany, 22081|
|Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie||Active, not recruiting|
|St. Augustin, Germany, 53757|
|Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie||Recruiting|
|Krakow, Poland, 31503|
|Klinika Kardiologii i Reumatologii Dzieciecej||Recruiting|
|Lodz, Poland, 91-738|
|Narodny ustav reumatickych chorob, Klinicke oddelenie||Recruiting|
|Piestany, Slovakia, 92112|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|