EUCTR2016-004990-42-AT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled,Parallel Group Study to Evaluate the Efficacy ofTocilizumab as a Remission-Induction andGlucocorticoid-Sparing Regimen in Subjects withNew-Onset Polymyalgia Rheumatica (PMR-SPARE) - PMR-SPARE
Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie0 个研究点目标入组 36 人开始时间: 2017年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •Diagnosis of PMR as confirmed by the investigator at screening and at baseline, fulfilment (also in retrospect) of the provisional 2012 ACR-EULAR classification criteria
- •Diagnosis of PMR established at, or up to 2 weeks before the screening visit
- •GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose between 12.5 and 25mg/day prednisone
- •Willing and able to receive oral prednisone 20mg/day at randomization and to follow a pre-specified tapering regimen
- •Willing to receive treatment for prevention of GC-induced bone loss
- •No evidence of active infection with Mycobacterium tuberculosis (screening performed according to national guidelines) and willing to take TB prophylaxis in case of evidence of latent TB
- •Willing and being able to understand and follow the study procedures
- •Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)
- •Written informed consent.
- •Female and Male subjects from 18 years old and higher
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended
- •GC treatment of PMR >2 weeks
- •Conditions other than PMR requiring continuous or intermittent treatment with oral or parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs was >1 months before screening
- •Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- •Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
- •Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20
- •Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline
- •Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •Previous treatment with Tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis)
- •Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- •History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- •Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn´s disease)
- •Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN
- •Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL (168 µmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study, if their estimated glomerular filtration rates (GFR) are > 30
- •Total Bilirubin > ULN
- •Any history of recent serious bacterial, viral, fungal, or other opportunistic infections
- •Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C
- •Positive QuantiFERON TB test, history of Tuberculosis, or active Tuberculosis-infection, without at least 4 weeks of adequate therapy for Tuberculosis
- •Active infection with EBV as defined by EBV viral load > 10,000 copies per mL of whole blood
- •Any of the following hematologic abnormalities, confirmed by repeat tests:
- •a. White blood count < 3,000/µL or > 14,000/µL;
- •b. Lymphocyte count < 500/ µL;
- •c. Platelet count < 100,000/µL;
- •d. Hemoglobin < 8.0 g/dL; or
- •e. Neutrophil count < 2,000 cells/µL
- •Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- •Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
- •Any medical or psychological condition that in the opinion of the Principal Investigator would interfere with safe completion of the trial
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