Trial record 17 of 45 for:    Open Studies | "Arthritis, Juvenile Rheumatoid"

Long-Term Safety Study Of CP-690,550 In Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 22, 2011
Last updated: February 8, 2015
Last verified: February 2015

Evaluate long-term safety and tolerability of CP-690,550 in patients with JIA, who have previously participated in CP-690,550 JIA studies.

Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 290
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)
Arms Assigned Interventions
Experimental: CP-690,550 Drug: CP-690,550

CP 690,550 in oral solution administered twice daily (BID) to patients according to weight as indicated below:

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 and over 5 5 For patients weighing 40 kg or more, CP 690,550, 5 mg BID is administered in tablet form or oral solution according to patient preference.


Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric patients with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying /index study and in the opinion of the investigator have sufficient evidence of RA disease activity to warrant use of CP-690,550 as a DMARD.
  • Patients turning 18 years of age during participation in the qualifying /index study or subsequently will be eligible for participation in this study.

Exclusion Criteria:

  • Systemic JIA with active systemic features, persistent oligoarthritis, and undifferentiated JIA.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01500551

Contact: Pfizer Call Center 1-800-718-1021

United States, Oregon
Randall Children's Hospital at Legacy Emanuel Not yet recruiting
Portland, Oregon, United States, 97227
Klinikum Bad Bramstedt Active, not recruiting
Bad Bramstedt, Germany, 24576
PRI - Pediatric Rheumatology Research Institute GmbH Active, not recruiting
Bad Bramstedt, Germany, 24576
Hamburger Zentrum fuer Kinder - und Jugendrheumatologie 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 Not yet recruiting
Lodz, Poland, 91-738
Narodny ustav reumatickych chorob, Klinicke oddelenie Recruiting
Piestany, Slovakia, 921 12
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01500551     History of Changes
Other Study ID Numbers: A3921145, 2011-004915-22
Study First Received: December 22, 2011
Last Updated: February 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on March 25, 2015