ISRCTN75313566已完成未知
A Phase II randomised study of oral prednisolone in early diffuse cutaneous systemic sclerosis (initially double-blind, then switched to open-label because of COVID-19)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
2020 Protocol article in https://journals.sagepub.com/doi/full/10.1177/2397198320957552 protocol (added 11/09/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients presenting with diffuse cutaneous systemic sclerosis with skin involvement extending to the proximal limb and/or trunk
- •2. Male or female age = 18 years
- •3. Skin involvement of less than 3 years defined by patient report or clinician opinion
- •4. Patient is able and willing to follow the requirements of the study
- •5. Fully written informed consent
排除标准
- •Current participant exclusion criteria as of 27/04/2020:
- •1. Patients with significant uncontrolled Stage 1 Hypertension (clinic BP > 140/90mmHg). Patients with previous hypertension which is controlled (clinic BP < 140/90mmHg) for at least 4 weeks are considered eligible
- •2. Previous renal crisis or significant renal impairment (estimated Glomerular Filtration Rate (eGFR) < 40 ml/min)
- •3. Patients currently on steroid therapy, or previous steroid therapy within the last 4 weeks, with the exception of inhaled steroids for respiratory diseases or topical steroids for skin disease
- •4. Patients currently participating in another randomised controlled trial of an investigational agent or device, or previous participation within the last 30 days
- •5. Patients currently receiving an immunosuppressant or biologic therapy the dose of which has changed in the last 4 weeks prior to the baseline visit, or is likely to change during the first 3 months of study treatment
- •6. Patients with major myositis or inflammatory arthritis. Patients with low level myositis or inflammatory arthritis are eligible for inclusion (for example, in the case of myositis, a creatine kinase less than 4 times the upper limit of normal or myositis only demonstrable on magnetic resonance imaging).
- •7. Female patients who are pregnant at time of screening
- •8. Patients with significant inflammatory bowel disease as judged by the investigator
- •9. It is important that patients do not suddenly stop taking the study medication
- •Previous participant exclusion criteria:
- •1. Patients with significant uncontrolled Stage 1 Hypertension (clinic BP > 140/90mmHg). Patients with previous hypertension which is controlled (clinic BP < 140/90mmHg) for at least 4 weeks are considered eligible
- •2. Previous renal crisis or significant renal impairment (estimated Glomerular Filtration Rate (eGFR) < 40 ml/min)
- •3. Patients currently on steroid therapy, or previous steroid therapy within the last 4 weeks, with the exception of inhaled steroids for respiratory diseases
- •4. Patients currently participating in another randomised controlled trial of an investigational agent or device, or previous participation within the last 30 days
- •5. Patients currently receiving an immunosuppressant or biologic therapy the dose of which has changed in the last 4 weeks, or is likely to change during the first 3 months of study treatment
- •6. Patients with major myositis or inflammatory arthritis. Patients with low level myositis or inflammatory arthritis are eligible for inclusion (for example, in the case of myositis, a creatine kinase less than 4 times the upper limit of normal or myositis only demonstrable on magnetic resonance imaging).
- •7. Female patients who are pregnant at time of screening
- •8. Patients with significant inflammatory bowel disease as judged by the investigator
- •9. It is important that patients do not suddenly stop taking the study medication
研究者
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