EUCTR2015-005389-51-FR进行中（未招募）1 期
Safety and Efficacy of tocilizuMAb versus placebo in Polymyalgia rHeumatica with glucocORticoid dEpendence SEMAPHORE
CHRU DE BREST0 个研究点目标入组 100 人开始时间: 2016年6月27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
- 100
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
- •-Age older than 50 years
- •-Having previously
- •-Fulfilled the Chuang criteria
- •-Be successfully treated with GCs = 15mg (CRP = 10 mg/l or ESR = 20 mm before GCs treatment and < 10 mg/dl (or ESR < 20 mm/h) after)
- •- And currently
- •-Being treated with schedule close to the 2015 ACR/EULAR recommendation and Unable to taper GCs < 10mg
- •-PMR-AS > 10
- •-Absence of signs or symptoms of other musculoskeletal or connective tissue conditions
- •-Able to give informed consent
- •-Concomitant treatments with méthotrexate or hydroxychloroquine are permitted if stable dose since 3 months.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General Exclusion Criteria:
- •-Clinical symptoms of giant cell arteritis
- •-Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease
- •-History of major organ or haematopoietic stem cell/marrow transplant
- •-Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
- •-Planned surgical procedure within 12 months after randomization.
- •-History of malignant neoplasm within the last 5 years.
- •-Current active infection
- •Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data:
- •Exclusions Related to Prior or Concomitant Therapy
- •-Previous treatment with cell-depleting therapies, including investigational agents, including
- •but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
- •-Treatment with IV gamma globulin or plasmapheresis within 6 months of baseline
- •-Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
- •-Previous treatment with TCZ
- •-Immunization with a live/attenuated vaccine within = 4 weeks prior to baseline
- •-Treatment with cyclosporine A, azathioprine, or MMF within 4 weeks of baseline
- •-Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of baseline
- •-Previous treatment with tofacitinib
- •-Treatment with cyclophosphamide within 6 months of baseline
- •Exclusions Related to General Safety
- •-History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
- •-Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary
- •(including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled
- •diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries,
- •or gastrointestinal (GI) disease
- •-History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative
- •lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI
- •conditions that might predispose a patient to perforations
- •-Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other
- •infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease,
- •hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- •-Active TB requiring treatment within the previous 3 years Patients should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment. Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible.
- •-Primary or secondary immunodeficiency (history of or currently active)
- •-Pregnant women and females who are breastfeeding
- •-Female of childbearing potential must have a negative serum pregnancy test within 28 days of randomization. Females of child-bearing potential may participate in this trial only if using a reliable means of contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD) during study treatment and for minimum of 3 months after last dose of TCZ.
- •-Males of reproductive potential who are not willing to use an effective method of
- •contraception, such as condom, sterilization, or true abstinence throughout study and for a
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