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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01513902
• Date of registration: 17/01/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
• Scientific 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)
• Date of first enrolment: March 2013
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01513902
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Germany, Hungary, Poland, Slovakia, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: CP-690,550

Primary Outcome(s)

Number of Participants With Clinically Significant Vital Signs Abnormalities [Time Frame: Baseline up to Day 5]

Apparent Oral Clearance (CL/F) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Number of Participants With Laboratory Test Abnormalities [Time Frame: Baseline up to Day 5]

Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities [Time Frame: Baseline up to 28 days after the last dose of study drug (Day 5)]

Secondary Outcome(s)

Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Taste Assessment [Time Frame: Day 1, Day 5]

Plasma Decay Half-Life (t1/2) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Apparent Volume of Distribution (Vz/F) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) [Time Frame: Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose]

Secondary ID(s)

A3921103

2011-004914-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/07/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01513902