2024-518653-41-00招募中3 期
RANDOMIZED, CONTROLLED, OPEN TRIAL OF TWO STANDARDIZED DECLINE SCHEMES, FAST (NORTH AMERICAN) AND SLOW (EUROPEAN) RESPECTIVELY, OF CORTISONE IN GIANT CELL ARTERITIS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- In each of the two arms (28- and 52-week regimens): number of patients in complete remission without relapse at S52, based on total number of patients included
研究概览
简要总结
To compare in giant cell arteritis (GCA) the rate of complete remission without any relapse in the two arms of corticosteroid therapy (long regimen of 52 weeks versus short regimen of 28 weeks) at week 52 (W52). The working hypothesis is to verify the non-inferiority of the shortened American scheme, in comparison to the extended French and European scheme.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 50 years old
- •Diagnosis of ACG based on the presence of two of the 4 ACR 1990 bio-clinical criteria (i.e. age > 50 years and unusual headache and/or tenderness in the temporal artery pathway and/or biological inflammatory syndrome (defined as c-reactive protein >5 mg/l or sedimentation rate >50 mm at first hour) and the mandatory presence of one of the following 3 criteria: positivity of a temporal artery biopsy or evidence of large-vessel vasculitis (on aortic angioscan, positron emission tomography or MRI angiography) or positivity of a temporal artery echo-Doppler performed by a recognized, experienced physician (radiologist or vascular physician).
- •Oral corticosteroid therapy started no more than 14 days ago, excluding boluses
- •Patient registered with the social security system
- •Patient who has given written consent
排除标准
- •Oral corticosteroid therapy started more than 14 days ago, excluding bolus therapy
- •Persons under court protection, guardianship or curatorship
- •Hypersensitivity to prednisone
- •Any infectious condition requiring systemic treatment
- •Evolving viruses (including hepatitis, herpes, chickenpox, shingles)
- •Patient on immunosuppressive therapy at inclusion
- •Psychotic states not yet controlled by treatment
- •Immunization with a live vaccine within 8 weeks of starting treatment
- •Pregnant women (for non-menopausal women, negative high-sensitivity pregnancy test)
- •Women of childbearing age without effective contraception
- •Giant cell arteritis in relapse
- •Persistent severe dementia
- •Non-observant patient
- •Patient living more than 150 km from the investigating center
结局指标
主要结局
In each of the two arms (28- and 52-week regimens): number of patients in complete remission without relapse at S52, based on total number of patients included
In each of the two arms (28- and 52-week regimens): number of patients in complete remission without relapse at S52, based on total number of patients included
次要结局
- - Measurement of the number of 1st relapses at S28 and S52 / number of patients included - Measurement of the number of 2nd relapses at S28 and S52 / number of patients included
- - Measurement of extremes, means and medians of time to 1st and 2nd relapses
- - Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52
- - Measuring the number of patients with cortico-dependent disease at S52
- measurement of blood pressure, weight, glycemia, glycated hemoglobin, biochemistry, infectious complications, fracture complications, glaucoma, cataracts. Screening in both arms for the onset or decompensation of type 2 diabetes and any cardiovascular events. Bone densitometry (at baseline, S28 and S52) and adverse events attributable to corticosteroid therapy as soon as consent was signed and for the duration of the study.
研究者
Investigateur coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (6)
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