Use of Acthar in Rheumatoid Arthritis Related Flares
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- DAS28
研究概览
简要总结
This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.
详细描述
Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status.
Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must meet 1987 ACR criteria
- •Age > 18 years of age
- •Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2
- •Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
- •Stable prednisone <10mg or equivalent
- •Power Doppler score of >=10
排除标准
- •Prior treatment with Acthar in the past 2mos
- •Meet one of the above RA flare requirements
- •Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)
研究组 & 干预措施
40 Units
40 units of Acthar per week
干预措施: Acthar (Drug)
80 Units
80 units of Acthar twice per week
干预措施: Acthar (Drug)
结局指标
主要结局
DAS28
时间窗: Baseline to 2 Weeks
DAS28 will be calculated. The change in the scores will be analyzed between the two groups.
Ultrasound Power Doppler Score
时间窗: Baseline to 2 Weeks
Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups.
DAS28
时间窗: Baseline to 4 Weeks
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6.
Power Doppler Ultrasound Score
时间窗: Baseline to 4 Weeks
34 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.
次要结局
- Ultrasound Grey Scale Synovial Hypertrophy score(Baseline to 2 Weeks)
- HAQ-DI(Baseline to 4 Weeks)
- Ultrasound Grey Scale Synovial Hypertrophy Score(Baseline to 4 Weeks)
研究者
Veena Ranganath, MD, MS
Assistant Clinical Professor
University of California, Los Angeles