Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
研究概览
简要总结
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
详细描述
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 year of age and older
- •RA diagnosis by American College of Rheumatology criteria
- •Active disease (CDAI > 10)
- •Have received at least are biologic agent for at least 6 months
- •May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
- •No current active infections requiring antibiotics
- •Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)
排除标准
- •Less than 18 years of age
- •Unable or unwilling to give Informed Consent
- •Have an active infection requiring the use of antibiotics
- •Women who are pregnant
- •Uncontrolled hypertension
- •Abnormal renal function
- •Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
研究组 & 干预措施
ACTHAR Gel
Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
干预措施: ACTHAR gel (Drug)
结局指标
主要结局
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
时间窗: 12 weeks
percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
次要结局
- Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12(12 weeks)
- Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12(12 weeks)
- Patient Reported Changes in Fatigue Between Week 0 and Week 12(12 weeks)
- Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12(12 weeks)
研究者
Dana Ascherman
Professor
University of Pittsburgh