EUCTR2011-004915-22-IT进行中（未招募）1 期
A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550 FORTREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
试验速览
- 阶段
- 1 期
- 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
- •1. Pediatric patients with JIA aged from 2 to less than 18 years who met entry criteria
- •for the qualifying/index study and in the opinion of the investigator have sufficient
- •evidence of RA disease activity to warrant use of CP-690,550 as a DMARD. Patients
- •turning 18 years of age during participation in the qualifying/index study or
- •subsequently will be eligible for participation in this study.
- •2. The patient has discontinued disallowed concomitant medications for the required
- •time prior to the first dose of study drug, as defined in Appendix 1, and is taking only
- •those concomitant medications in doses and frequency allowed by the protocol.
- •3. Fertility:
- •a. Sterile male, or non sterile male. If the patient is a non sterile male on
- •background medications (including DMARDs) that require male
- •contraceptive precautions according to the local drug label and is sexually
- •active with a female partner of child-bearing potential, he and his partner must
- •be practicing effective contraceptive measures.
- •b. Females of childbearing potential must be using a reliable means of
- •contraception (abstinence being a possible option) throughout the study and
- •and for at least one ovulatory cycle after CP-690,550 treatment is discontinued.
- •4. For patients receiving methotrexate (MTX) treatment, MTX may be administered
- •either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week.
- •5. For patients receiving leflunomide treatment, leflunomide may be administered
- •according to the following dosing scheme:
- •? 10 mg every other day for patients weighing less than 20 kg,
- •? 10 mg every day for patients weighing between 20 and 40 kg,
- •? 20 mg every day for patients weighing over 40 kg;
- •Or as according to local standards.
- •6. A negative QuantiFERON-TB Gold In-Tube test4 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.
- •7. Evidence of a personally signed and dated informed consent document with assent as
- •appropriate indicating that the patient (or a legally acceptable representative) has been
- •informed of all pertinent aspects of the study.
- •8. 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
- •1. Systemic JIA with active systemic features, persistent oligoarthritis, and
- •undifferentiated JIA.
- •2. Blood dyscrasias, including:
- •a. Hgb <10 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/1.73 m2 calculated using the Schwartz formula
- •(Appendix 4) at the Screening Visit.
- •4. Current or recent history of uncontrolled clinically significant renal, hepatic,
- •hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological
- •5. AST or ALT >/=1.5 times the upper limit of normal or any other clinically significant
- •laboratory abnormality.
- •For all patients:
- •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. Patients taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors
- •(Appendix 5).
- •11. Patients taking potent and moderate CYP3A4 inducers (Appendix 5).
- •12. Participation in studies of investigational compounds (excluding qualifying/index
- •study with CP-690,550) within 4 weeks or 5 half-lives (whichever is longer) prior to
- •the first dose of study drug. Patients cannot participate in studies of other
- •investigational compounds at any time during their participation in this study.
- •Exposure to investigational biologics should be discussed with the Pfizer Medical
- •13. Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies
- •[eg, almetuzumab (CAMPATH?), alkylating agents (eg, cyclophosphamide or
- •chlorambucil), total lymphoid irradiation, etc]. Patients 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.
- •14. Pregnant or nursing females; females of childbearing potential who are unwilling or
- •unable to use an acceptable method of contraception as outlined in this protocol
- •during the study and for least one ovulatory cycle after the last dose of study
- •medication.
- •15. Intramuscular or intravenous corticosteroids in the 4 weeks preceding first dose of
- •study medication.
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