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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01500551
First received: December 22, 2011
Last updated: March 17, 2014
Last verified: March 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
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
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
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: March 17, 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 Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014