NCT00305539已完成3 期
HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- To determine the influence of an initial treatment of 3 months with adalimumab, 40 mg every other week, in the percentage of patients achieving at 6 months (week 26), a decrease in their corticosteroid treatment to a dose equal or lower than 0,1 mg/kg
研究概览
简要总结
Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.
详细描述
The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •ACR criteria for Giant cell arteritis (HUNDER 1990)
- •Positive Temporal artery biopsy
- •Plus standard inclusion criteria for Humira protocols
排除标准
- •Prednisone treatment for a different disease at a dose >15 mg/day
- •Corticoid treatment for GCA more than 10 days
- •GCA treatment with prednisone > 1 mg/kg whatever period of time
- •GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or steroid bolus
- •Recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality (diplopia, hallucination)
- •Plus standard exclusion criteria for Humira protocols
研究组 & 干预措施
1
Active Comparator
干预措施: adalimumab (Drug)
2
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
To determine the influence of an initial treatment of 3 months with adalimumab, 40 mg every other week, in the percentage of patients achieving at 6 months (week 26), a decrease in their corticosteroid treatment to a dose equal or lower than 0,1 mg/kg
时间窗: 1 year
次要结局
- To determine the influence of an initial treatment of 3 months with adalimumab on the total dose of corticosteroids determined by AUC (area under the curve)(1 year)
- To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Methotrexate as Remission Maintenance Therapy After Remission-Induction With Tocilizumab and Glucocorticoids in Giant Cell ArteritisGiant Cell ArteritisNCT05623592University of Bonn52
招募中
3 期
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids TaperingGiant Cell ArteritisNCT04012905University Hospital, Caen150
Unknown
3 期
Giant Cell Arteritis and Anakinra TrialGiant Cell ArteritisNCT02902731University Hospital, Caen70
已完成
1 期
Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and TocilizumabGiant Cell ArteritisNCT03745586Insel Gruppe AG, University Hospital Bern18
已完成
2 期
Tocilizumab for Patients With Giant Cell ArteritisGiant Cell ArteritisNCT01450137Insel Gruppe AG, University Hospital Bern30