Glucocorticoid withdrawal and glucocorticoid-induced adrenal insufficiency: a randomized controlled multicenter trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia [serum sodium < 135 millimole (mM)], hyperkalemia [serum potassium > 5 mM], hypoglycemia [plasma glucose < 3.5 mM]); whichever occurs first.
研究概览
简要总结
To perform the first adequately powered randomized, placebocontrolled, multicenter noninferiority trial, comparing immediate termination of systemic glucocorticoid treatment with a tapering regime over four weeks. The hypothesis is tested that in patients treated with systemic glucocorticoids for various inflammatory disorders, rapid termination of treatment will not result in a worse clinical outcome than a tapering regime over four weeks.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Age ≥ 18 years
- •Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion
- •Therapy over ≥ 28 days,
- •≥ 7.5 mg prednisone-eqivalent average daily dose until time of inclusion,
- •cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion
- •Tapering not or no longer mandatory to treat underlying disease
排除标准
- •Primary adrenal failure
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural)
- •Incapability to administer glucocorticoid cover treatment in situations of stress
- •Inability or unwillingness to provide informed consent
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion.
- •Known or suspected non-compliance
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
结局指标
主要结局
Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia [serum sodium < 135 millimole (mM)], hyperkalemia [serum potassium > 5 mM], hypoglycemia [plasma glucose < 3.5 mM]); whichever occurs first.
Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia [serum sodium < 135 millimole (mM)], hyperkalemia [serum potassium > 5 mM], hypoglycemia [plasma glucose < 3.5 mM]); whichever occurs first.
次要结局
- Time to first occurrence of individual components of the primary outcome
- Cumulative overall systemic glucocorticoid dose
- Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
- Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease
- General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100
- Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, and blood pressure
- Performance in 250 mcg ACTH (Synacthen®) test
- In patients hospitalized at study entry: length of hospital stay
研究者
Prof. MD Jonas Rutishauser
Scientific
Kantonsspital Baden AG