NL-OMON52164撤回3 期
A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) - A3921145
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •Subjects eligibility should be reviewed and documented by an appropriately
- •investigator before subjects are included in the study. All subjects must meet
- •Inclusion Criteria 1-11 to be eligible for enrollment into the study: 1)
- •Pediatric subjects 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 JIA disease activity to warrant use of tofacitinib
- •as a DMARD. Subjects turning 18 years of age during participation in the
- •qualifying/index study or subsequently will be eligible for participation in
- •this study. 2) The subject 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
- •frequencies allowed by the protocol. 3) Fertile male subjects and female
- •subjects of childbearing potential who are, in the opinion of the
- •investigator, sexually active and at risk for pregnancy with their partner(s)
- •must be using a highly effective method of contraception as outlined in this
- •protocol throughout the study and for at least 28 days after the last dose of
- •study medication. 4) Subjects must have previously completed participation in a
- •qualifying study of tofacitinib for the treatment of JIA. Subjects who have
- •required earlier discontinuation of treatment in a qualifying study for reasons
- •other than tofacitinib related serious adverse events may be eligible. 5) For
- •subjects receiving methotrexate (MTX) treatment, MTX may be administered either
- •orally or parenterally at doses not to exceed 25mg/week or 20 mg/m2/week,
- •whichever is lower. Subjects taking methotrexate must be taking folic acid or
- •folinic acid in accordance with local standards. 6)For subjects receiving an
- •oral glucocorticoid, glucocorticoids may be administered at a maximum dose of
- •0.20 mg/kg/day or 10 mg/day, prednisone or equivalent, whichever is lower.
- •7)For subjects receiving leflunomide treatment, leflunomide may be administered
- •according to the following dosing scheme:10 mg every other day for subjects
- •patients weighing less than 20 kg; 10 mg every day for subjects weighing
- •between 20 and 40 kg,; 20 mg every day for subjects weighing over 40 kg; Or as
- •according to local standards. 8)For subjects receiving sulfasalazine,
- •chloroquine, or hydroxychloroquine treatment, these medications may be
- •administered according to local standards. 9)Evidence of a personally signed
- •and dated informed consent document with assent as appropriate indicating that
- •the subject (or a legally acceptable representative/ parent(s)/legal guardian)
- •has been informed of all pertinent aspects of the study. 10)Subjects who are
- •willing and able to comply with all scheduled visits, treatment plan,
- •laboratory tests, and other study procedures. 11)Subjects for whom, in the
- •Investigator*s opinion, treatment with tofacitinib is considered clinically
- •appropriate while also taking into consideration currently available therapies
- •and prior response to these therapies. Subjects who enroll outside the 14 day
- •window of the EOS Visit of their qualifying/index study must also meet
- •Inclusion Criterion 12 to be eligible for enrollment into the study: 12) No
- •evidence of active tuberculosis (TB) or inadequately
排除标准
- •Subjects presenting with any of the following will not be included in the
- •study: For subjects who enroll outside the 14 day window of the EOS Visit
- •of their qualifying/index study (Exclusion 1-3):
- •1) Blood dyscrasas, 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. e.
- •Lymphocyte count of <0.75 x 109/L. 2) Estimated glomerular filtration rate
- •[GFR] <40 mL/min/1.73 m2 calculated using Bedside Schwartz formula (Appendix 5)
- •at the Screening Visit. 3) Aspartate aminotransferase (AST) or alanine
- •aminotransferase (ALT) *1.5 times the upper limit of normal or any other
- •clinically significant laboratory abnormality. For all subjects: 4)
- •Persistent oligoarthritis, and undifferentiated JIA. 5) Current or recent
- •history of uncontrolled clinically significant renal, hepatic, hematological,
- •gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 6)
- •History of any other rheumatic autoimmune disease, other than Sjogren*s
- •syndrome. 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) Chronic infections. b) 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: c) Any treated infections within 2 weeks of baseline
- •visit. (excluding those treated with topicals only) d) A subject known to be
- •infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- •virus. e) History of infected joint prosthesis with prosthesis still in situ.
- •9) History of recurrent (more than one episode) herpes zoster or a single
- •episode of disseminated herpes zoster or a single episode of disseminated
- •(both oral and gential lesions simutaneously, or widespread lesions not
- •contaminaed to oral or gential regions alone) herpes simplex. 10) Previously
- •failed treatment with another JAK inhibitor, such as baricitinib. 11) Subjects
- •taking potent and moderate cytochrome P450 3A4 (CYP3A4) inhibitors (Appendix
- •6). 12) Subjects taking potent and moderate CYP3A4 inducers (Appendix 6).13)
- •Participation in studies of investigational compounds (excluding
- •qualifying/index study with tofacitinib) within 4 weeks or 5 half-lives
- •(whichever is longer) prior to the first dose of study drug. Subjects 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 Monitor. 14) Any prior treatment
- •with non B cell-specific lymphocyte depleting agents/therapies [eg. almetuzumab
- •(CAMPATHÒ), 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. 15) Pregnant
- •or nursing females are excluded. 16) Intramuscular or intravenous
- •corticosteroids in the 4 weeks preceding fi
研究者
相似试验
进行中（未招募）
1 期
A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisRheumatoid arthritisEUCTR2006-005035-19-GBPfizer Inc, 235 East 42nd Street, New York, NY 100174,481
进行中（未招募）
1 期
A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod ArthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2006-005035-19-IEPfizer Inc, 235 East 42nd Street, New York, NY 100174,500
进行中（未招募）
1 期
A Long-Term, Open-Label, Study for Treatment of JIAJUVENILE IDIOPATHIC ARTHRITIS (JIA)MedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2011-004915-22-NLPfizer Inc, 235 East 42nd Street, New York, New York 10017340
进行中（未招募）
1 期
A Long-Term, Open-Label, Study for Treatment of JIAEUCTR2011-004915-22-SKPfizer Inc,340
进行中（未招募）
1 期
A Long-Term, Open-Label, Study for Treatment of JIAEUCTR2011-004915-22-GBPfizer Inc.340