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临床试验/EUCTR2011-006022-25-BE
EUCTR2011-006022-25-BE进行中（未招募）1 期

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS

F. Hoffmann-La Roche Ltd0 个研究点目标入组 250 人开始时间: 2013年6月17日最近更新:
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适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
250
研究概览入排标准研究者记录与标识符相似试验

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 GCA classified according to the following criteria:
  • •Age greater than or equal to 50 years
  • •History of ESR (greater than 50 mm/hour)
  • •AND at least one of the following:
  • •Unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)
  • •Symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness
  • •AND at least one of the following:
  • •Temporal artery biopsy revealing features of GCA
  • •Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography computed tomography angiography (PET-CT)
  • •New-onset or refractory active disease defined as follows:
  • •New onset: diagnosis of GCA within 6 weeks of baseline visit
  • •Refractory: diagnosis of GCA >6 weeks before baseline visit and previous treatment with =40 mg/day prednisone (or equivalent) for at least 2 consecutive weeks at any time
  • •Active GCA within 6 weeks of baseline visit (active disease defined as the presence of clinical signs and symptoms [cranial or PMR] and ESR greater than or equal to 30 mm/hour or CRP greater than or equal to 1 mg/dL)
  • •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 100
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 150

排除标准

  • •- Recent or incoming major surgery
  • •- Organ transplantation recipient (except corneas within 3 months prior to baseline visit)
  • •- Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening
  • •- Prior treatment with any of the following:
  • •- Investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening visit
  • •- Cell-depleting agents (e.g. anti CD 20)
  • •- Tocilizumab
  • •- Tofacitinib
  • •- Alkylating agents including CYC within 6
  • •months of baseline
  • •- HCQ, CsA, AZA, or MMF within 4 weeks
  • •of baseline
  • •- Tumor necrosis factor inhibitors within 2-8 weeks of baseline
  • •- Anakinra within 1 week of baseline
  • •- Corticosteroids for conditions other than
  • •- IV corticosteroids within 6 weeks of
  • •- History of severe allergic reactions to
  • •monoclonal antibodies
  • •- Evidence of serious uncontrolled
  • •concomitant disease (e.g. cardiovascular,
  • •respiratory, renal, endocrine)
  • •- Current liver disease that could interfere
  • •with the trial as determined by the
  • •investigator
  • •- History of diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation
  • •- Infections:
  • •- Active current or history of recurrent
  • •bacterial, viral fungal, mycobacterial, or
  • •other infection

研究者

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