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 2016 by Pfizer
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 22, 2011
Last updated: February 2, 2016
Last verified: February 2016
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: 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)

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
All patients will be in tofacitinib treatment group.
Drug: CP-690,550

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, Xeljanz
Drug: 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

Detailed Description:

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.


Ages Eligible for Study:   2 Years to 17 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 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
Sponsors and Collaborators
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  2011-004915-22 
Study First Received: December 22, 2011
Last Updated: February 2, 2016
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

ClinicalTrials.gov processed this record on February 04, 2016