2024-517406-29-00已完成2 期
A trial of prednisolone in combination with SPI-62 or placebo in participants with polymyalgia rheumatica (PMR)
Sparrow Pharmaceuticals Inc.9 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2024年11月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 9
- 主要终点
- Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein
研究概览
简要总结
To identify whether a prednisolone dose adjustment is necessary to provide equivalent efficacy when administered with SPI-62 in subjects with PMR and, if so, estimate the adjustment.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Follow-up period
- 盲法
- Single (Subject)
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
- •Written informed consent.
- •Diagnosis of PMR according to EULAR/ACR classification criteria
- •Absence of PMR relapse based on symptoms and acute phase markers.
- •Daily oral prednisolone 10 mg dose that will have been stable for at least 1 week at the Baseline Visit and is expected to remain stable during the treatment period.
排除标准
- •Any contraindication for prednisolone administration.
- •A diagnosis or any clinical features of giant cell arteritis.
- •Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- •Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- •Use of other medications likely to interfere with trial assessments.
- •History or diagnosis of endogenous hypercortisolism.
- •Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.
结局指标
主要结局
Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein
Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein
次要结局
- Oral glucose tolerance test glucose area under the concentration‑time curve, osteocalcin, urinary 11β-hydroxysteroid dehydrogenase type 1 ratio
研究者
Scientific contact point
Scientific
Sparrow Pharmaceuticals Inc.
研究点 (9)
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