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 August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01500551
First received: December 22, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group 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.


  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01500551

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Germany
Klinikum Bad Bramstedt Recruiting
Bad Bramstedt, Germany, 24576
PRI - Pediatric Rheumatology Research Institute Recruiting
Bad Bramstedt, Germany, 24576
Universitaets-Kinderklinik Charite SPZ Kinderrheumatologie Not yet recruiting
Berlin, Germany, 13353
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie Recruiting
Hamburg, Germany, 22081
Schoen Klinik Hamburg Eilbek Recruiting
Hamburg, Germany, 22081
Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie Recruiting
St. Augustin, Germany, 53757
Poland
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
Slovakia
Narodny ustav reumatickych chorob, Klinicke oddelenie Not yet recruiting
Piestany, Slovakia, 921 12
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01500551     History of Changes
Other Study ID Numbers: A3921145
Study First Received: December 22, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Arthritis
Pediatric
Tofacitinib
Long-term
JIA
CP-690
550
tofacitinib
Xeljanz

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014