A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients Aged 2-18
- Conditions
- JUVENILE IDIOPATHIC ARTHRITISMedDRA version: 17.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-004914-40-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Patient eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before patients are included in the study. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
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 ACR definition of active joint) at the time of the first study drug administration.
1. The patient has discontinued prohibited concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 4 of the protocol, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
2. Fertility:
a. Sterile male, or non sterile male. If the patient is a non sterile male receiving MTX treatment and is sexually active with a female partner of child bearing potential, he and his partner must be using an acceptable method of contraception during the study, and after therapy for the duration according to the local drug label.
b. Females of childbearing potential must be using an acceptable method of contraception (abstinence being a possible option) starting at least 14 days prior to the first dose of study drug and continuing for at least one ovulatory cycle after the last dose of study drug.
3. For patients 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 up to the lesser of 20 mg/wk or 15 mg/m2/week.
4. 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.
5. Written informed consent for study participation obtained from parents or legal guardian, with assent as appropriate by the patient, depending on the level of the patient’s understanding.
6. Patients who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Systemic JIA, persistent oligoarthritis, undifferentiated arthritis. 2. Hgb <11 g/dL or Hct <33% (b) WBC <3.0 x 10 to the power of 9/L ; Neutr count <1.2 x 10 to the power of 9/L; Platelet count <100 x 10 to the power of 9/L; lymphocyte count <0,5 to the power of 9/L 3. Estimated GFR <40 mL/min by Schwartz formula. 4. Current or recent history of uncontrol. clinical. signific. renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5. AST or ALT =1.5XULN or other clinically significant lab. abnormality. 6. History of any other rheumatic autoimmune diseas. 7. History or current sympt. suggestive of any lymphoproliferative disorder (eg, Epstein Barr Virus related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and sympt. suggestive of current lymphatic disease). 8. Infections: Latent or active TB or any history of previous TB; Chronic infect; Any infection requiring hosp., parenteral antimicrobial therapy or judged to be opportunistic by the invest. within the 6 months prior to the first dose of study drug; Any treated infections within 2 weeks; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus; History of infected joint prosthesis with prosthesis still in situ. 9. History of recurrent or disseminated herpes zoster or disseminated herpes simplex. 10. Any condition possibly affecting drug absorption. 11. Potent and moderate CYP3A4 inhibitors. 12. Potent and moderate CYP3A4 inducers. 13. Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least: Anakinra and Etanercept, for 4 weeks; Adalimumab, for 6 weeks; Infliximab, for 8 weeks; Golimumab, for 10 weeks; Abatacept, tocilizumab and certolizumab pegol, for 12 weeks; Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold), for 8 weeks; Sulfasalazine, d penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, tacrolimus, and staphylococcal protein A immuno absorbant pheresis columns, for 4 weeks 14. Following treatments are disallowed during this study and must be discontinued prior to first dose of study drug for at least: Leflunomide, for 8 weeks. Alternatively, a washout procedure may be used; Ustekinumab, for 12 weeks; Alefacept must be discontinued for 8 weeks; UVB phototherapy for at least 2 weeks. Psoralens + UVA phototherapy (PUVA) for 4 weeks 15. Participation in studies of investigational compounds within 4 weeks or 5 half lives (whichever is longer) prior to the first dose of study drug or at any time during the study. 16. Any prior treatment with non B cell specific lymphocyte depleting agents/therapies [eg, almetuzuma, alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Subjects who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis. 17. Pregnant or nursing females; females of childbearing potential unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of study drug and for least one ovulatory cycle after the last dose 18. Intramuscular, intravenous or intraarticular corticosteroids in the 4 weeks preceding first dose of study drug 19. Vaccination with live or a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA. ;Secondary Objective: To evaluate taste acceptability of the oral formulation of CP 690,550 in pediatric patients with JIA.;Primary end point(s): - Oral clearance (CL/F) on Day 5.<br><br>- Safety and tolerability.<br>;Timepoint(s) of evaluation of this end point: Baseline/Day 1 and Day 5
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - AUCt, Cmax, tmax and half life.<br><br>-Evaluation of taste acceptability of oral formulation.<br>;Timepoint(s) of evaluation of this end point: Baseline/Day 1 and Day 5