EUCTR2011-005090-22-GB进行中（未招募）不适用
A study of efficacy and safety of delayed release prednisone in newly diagnosed cases of Giant Cell Arteritis - Efficacy and safety of delayed release prednisone in GCA
Southend Hospital0 个研究点开始时间: 2012年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 =50 years
- •New diagnosis of GCA within last 4 weeks
- •ESR >30 mm/h or CRP >10 mg/dl
- •Unequivocal clinical and laboratory picture of GCA either fulfilling American College of Rheumatology criteria or typical features (as assessed by clinician) including one or several of the following:
- •- New onset localised pain in the head after 50 years of age
- •- Jaw or tongue claudication
- •- Visual symptoms (amaurosis fugax, blurring and diplopia)
- •- Systemic symptoms not attributable to other causes
- •- Limb claudication
- •- Polymyalgia
- •- Abnormal temporal artery (tender, thickened, beading, decreased pulsation)
- •- Scalp tenderness
- •- Decreased visual acuity/visual field defect
- •- Anterior ischemic optic neuropathy (AION) or central retinal artery occlusion on fundoscopy
- •- Upper cranial nerve palsies
- •- Typical ischaemic complications of GCA (eg AION)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •GCA on steroid therapy longer than 4 weeks
- •Previous exposure to DMARD/biologic therapy
- •Serious or chronic infection in the last 3 months.
- •Diagnostic doubt
- •Failure to respond to high dose steroids within 5 days
- •Known other vasculitis
- •Patients with evolving ischemic symptoms requiring IV methylprednisolone
- •Patients unable to consent
研究者
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