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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis, Minnesota, 55454 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopathic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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.

2. For subjects receiving MTX treatment, minimum duration of therapy is 4 months and dose
stable for at least 6 weeks prior to first dose of study drug. MTX may be administered
either orally or parenterally at doses not to exceed 20 mg/wk or 15 mg/m2/week.

3. A negative QuantiFERON-TB Gold In-Tube test performed within the 3 months prior to
screening. A negative PPD test can be substituted for the QuantiFERON-TB Gold In-Tube
test only if the central laboratory is unable to perform the test or cannot determine
the results to be positive or negative and the Pfizer medical monitor approves it, on
a case-by-case basis.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.

2. Current or recent history of uncontrolled clinically significant renal, hepatic,
hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological
disease.

3. History of any other rheumatic autoimmune disease.

4. Infections:

1. Latent or active TB or any history of previous TB.

2. Chronic infections.

3. Any infection requiring hospitalization, parenteral antimicrobial therapy or
judged to be opportunistic by the investigator within the 6 months prior to the
first dose of study drug.

4. Any treated infections within 2 weeks of Baseline visit.

5. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis
B or hepatitis C virus.

6. History of infected joint prosthesis with prosthesis still in situ.

5. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.

6. The biologic agents and DMARDs are disallowed at any time during this study. If a
subject needs to be treated with one of these agents, the subject should be
discontinued from the study.

7. Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks
prior to the first dose of study medication or is to be vaccinated with these vaccines
at any time during treatment or within 6 weeks following discontinuation of study
drug.

8. Subjects with a malignancy or with a history of malignancy with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

NCT01513902
Pfizer
Completed
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

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Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
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)
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).
This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice daily for 5 days [except Day 5 when only morning dose will be given]) study in pediatric subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1 month of the completion of the Screening Visit. The study will consist of three cohorts based on the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than 12 years and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric subjects with JIA will participate in the study ensuring a total number of at least 24 pediatric evaluable subjects completing the PK period.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Juvenile Idiopathic Arthritis
  • 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 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. 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
    Other Name: Tofacitinib
  • 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 will be used for children weighing ?40 kg. Children less than 12 years of age with a body weight of ?40 kg 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
    Other Name: Tofacitinib
  • Drug: CP-690,550
    CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ?30 kg will have the option of taking oral solution or tablets, and children weighing <30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ?30 5 5
    Other Name: Tofacitinib
  • Experimental: Cohort 1
    Ages 12 to less than 18
    Intervention: Drug: CP-690,550
  • Experimental: Cohort 2
    Ages 6 to less than 12
    Intervention: Drug: CP-690,550
  • Experimental: Corhort 3
    Ages 2 to less than 6
    Intervention: Drug: CP-690,550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. For subjects receiving MTX treatment, minimum duration of therapy is 4 months and dose stable for at least 6 weeks prior to first dose of study drug. MTX may be administered either orally or parenterally at doses not to exceed 20 mg/wk or 15 mg/m2/week.
  3. A negative QuantiFERON-TB Gold In-Tube test performed within the 3 months prior to screening. A negative PPD test can be substituted for the QuantiFERON-TB Gold In-Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor approves it, on a case-by-case basis.

Exclusion Criteria:

  1. Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.
  2. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.
  3. History of any other rheumatic autoimmune disease.
  4. Infections:

    1. Latent or active TB or any history of previous TB.
    2. Chronic infections.
    3. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug.
    4. Any treated infections within 2 weeks of Baseline visit.
    5. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
    6. History of infected joint prosthesis with prosthesis still in situ.
  5. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
  6. The biologic agents and DMARDs are disallowed at any time during this study. If a subject needs to be treated with one of these agents, the subject should be discontinued from the study.
  7. Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug.
  8. Subjects with a malignancy or with a history of malignancy with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland,   Slovakia,   United States
Hungary
 
NCT01513902
A3921103
2011-004914-40 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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