EUCTR2011-004914-40-IT进行中（未招募）不适用
AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THEPHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 INPEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITHJUVENILE IDIOPATHIC ARTHRITIS (JIA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC.
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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, 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 test6 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
排除标准
- •Patients presenting with any of the following will not be included in the study: 1. Systemic JIA, persistent oligoarthritis, and undifferentiated arthritis. 2. Blood dyscrasias, including: a. Hgb <11 g/dL or Hct <33%.b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. 3. Estimated GFR <40 mL/min calculated using the Schwartz formula (Appendix 3) at the Screening Visit. 4. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5. AST or ALT >/-1.5 times the upper limit of normal or any other clinically significant laboratory abnormality. 6. History of any other rheumatic autoimmune disease. 7. History or current symptoms suggestive of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 8. Infections: a. Latent or active TB or any history of previous TB. b. Chronic infections. c. 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. d. Any treated infections within 2 weeks. e. A patient known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus. f. History of infected joint prosthesis with prosthesis still in situ. 9. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. 10. Any condition possibly affecting drug absorption (eg, gastrectomy). 11. Patients taking potent and moderate CYP3A4 inhibitors (Appendix 4). 12. Patients taking potent and moderate CYP3A4 inducers (Appendix 4). 13. The following biologic agents and DMARDs are disallowed at any time during this study. If a patient needs to be treated with one of these agents, the patient should be discontinued from the study: ? Anakinra (Kineret) and etanercept (Enbrel) must be discontinued for 4 weeks prior to first dose of study drug; ? Adalimumab (Humira) must be discontinued for 6 weeks prior to first dose of study drug; ? Infliximab (Remicade) must be discontinued for 8 weeks prior to first dose of study drug; ? Golimumab (Simponi TM) must be discontinued for 10 weeks prior to first dose of study drug; ? Abatacept (Orencia), tocilizumab (Actemra) and certolizumab pegol (Cimzia) must be discontinued for 12 weeks prior to first dose of study drug; ? Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold) must be discontinued for 8 weeks prior to first dose of study drug; ? Leflunomide (Arava) must be discontinued 8 weeks prior to first dose of study drug. Alternatively, a washout procedure using cholestyramine may be performed (eg, 240 mg/kg/24 hr divided TID, not to exceed 8 g/24 hours for 11 days. Cholestyramine to be given in a slurry in water, juice, or milk before meals for tolerability); ? Sulfasalazine, d-penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, tacrolimus, and staphylococcal protein A immuno-absorbant pheresis columns (eg, PROSORBA device/column) must be discontinued for 4 weeks prior to first dose of study drug.
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