Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

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:
NCT01513902
First received: January 17, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: CP-690,550
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-Label Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Pediatric Patients From 2 To Less Than 18 Years Of Age With Juvenile Idiopathic Arthritis (JIA)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Apparent Oral Clearance (CL/F) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve from time zero to end of dosing interval (AUCtau) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dos, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Plasma decay half-life (t1/2) [ Time Frame: Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose ] [ Designated as safety issue: No ]
  • Taste acceptability assessment questionnaire [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-690,550, Ages 12 to less than 18 Drug: CP-690,550

CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets (5 mg) will be used for children weighing >40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Children less than 12 years of age with a body weight of 40 kg and greater will have the option of taking oral solution or tablets.

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 5 5

Experimental: CP-690,550, Ages 6 to less than 12 Drug: CP-690,550

CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets (5 mg) will be used for children weighing >40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Children less than 12 years of age with a body weight of 40 kg and greater will have the option of taking oral solution or tablets.

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 5 5

Experimental: CP-690,550, Ages 2 to less than 6 Drug: CP-690,550

CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets (5 mg) will be used for children weighing >40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Children less than 12 years of age with a body weight of 40 kg and greater will have the option of taking oral solution or tablets.

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 5 5


  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 with active JIA (extended oligoarthritis, polyarthritis rheumatoid factor positive or negative, psoriatic arthritis, enthesitis related arthritis), in 5 or more joints (using American College Rheumatology definition of active joint) at the time of the first study drug administration.

Exclusion Criteria:

  • Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.
  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: NCT01513902

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

Locations
Germany
Pfizer Investigational Site Recruiting
Bad Bramstedt, Germany, 24576
Pfizer Investigational Site Not yet recruiting
Berlin, Germany, 13353
Pfizer Investigational Site Recruiting
Hamburg, Germany, 22081
Pfizer Investigational Site Recruiting
St. Augustin, Germany, 53757
Poland
Pfizer Investigational Site Recruiting
Krakow, Poland, 31-503
Pfizer Investigational Site Not yet recruiting
Lodz, Poland, 91-738
Slovakia
Pfizer Investigational Site 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: NCT01513902     History of Changes
Other Study ID Numbers: A3921103
Study First Received: January 17, 2012
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Arthritis
Pediatric
Tofacitinib
JIA

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 September 18, 2014