Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: CP-690,550; CP-690,550; CP-690,550
Intervention description: 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 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 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
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Arthritis; Pediatric; Tofacitinib; JIA

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).
    

Eligibility 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.