Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Ritchey-Camp Articular Index
研究概览
简要总结
It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.
详细描述
Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis of at least 2 years duration
- •On at least third biologic with a different mechanism of action for at least 12 weeks
- •Active disease as defined by at least 6 tender and 6 swollen joints
- •Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal
- •Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks
排除标准
- •Prior treatment with Acthar Gel
- •History of intolerance or allergy to glucocorticoids
- •Unstable diabetes
- •Active infection
研究组 & 干预措施
Repository corticotropin injection
Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
干预措施: Repository corticotropin injection (Drug)
结局指标
主要结局
Change From Baseline in the Ritchey-Camp Articular Index
时间窗: From baseline to week 16
Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.
Change From Baseline in the 20-item Health Assessment Questionnaire Score
时间窗: From baseline to week 16
Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.
次要结局
- Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)(From baseline to week 16)
- Change From Baseline in the C-Reactive Protein (CRP) Level(From baseline to week 16)
研究者
Nathan Wei, MD, FACP, FACR:
Nathan Wei, MD, FACP, FACR
Arthritis Treatment Center, Maryland