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

Juvenile Idiopathic Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513902
• Other study ID #: A3921103
• Secondary ID: 2011-004914-40
• Status: Completed
• Phase: Phase 1
• First received: January 17, 2012
• Last updated: February 26, 2016
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Germany	PRI - Pediatric Rheumatology Research Institute GmbH	Bad Bramstedt
Germany	Hamburger Zentrum fuer Kinder-und Jugendrheumatologie SchoenKlinik Hamburg Eilbek	Hamburg
Germany	Asklepios Klinik Sankt Augustin GmbH	Sankt. Augustin
Poland	Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie	Krakow
Poland	Klinika Kardiologii i Reumatologii Dzieciecej	Lodz
Slovakia	Narodny ustav reumatickych chorob	Piestany
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Clinical and Translational Science Institute Masonic Clinical Research Unit (Administration Only)	Minneapolis	Minnesota
United States	Explorer Clinic, University of Minnesota Children's Hospital	Minneapolis	Minnesota
United States	Randall Children's Hospital at Legacy Emanuel	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparent Oral Clearance (CL/F)		Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose	No
Primary	Number of participants with adverse events		Baseline up to Day 5	Yes
Secondary	Area under the curve from time zero to end of dosing interval (AUCtau)		Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose	No
Secondary	Maximum observed plasma concentration (Cmax)		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	No
Secondary	Time to reach maximum observed plasma concentration (Tmax)		Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose	No
Secondary	Apparent volume of distribution (Vz/F)		Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose	No
Secondary	Plasma decay half-life (t1/2)		Day 5 predose, 0.5, 1, 2, 4 and 8 hours post morning dose	No
Secondary	Taste acceptability assessment questionnaire		Baseline, Day 5	No

External Links

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