Use of Acthar in Rheumatoid Arthritis Related Flares
概览
- 阶段
- 4 期
- 干预措施
- Acthar
- 疾病 / 适应症
- Rheumatoid Arthritis (RA)
- 发起方
- Veena Ranganath, MD, MS
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- DAS28
- 状态
- 已完成
- 最后更新
- 2个月前
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, Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3) 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.
研究者
Veena Ranganath, MD, MS
Assistant Clinical Professor
University of California, Los Angeles
入排标准
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
80 Units
80 units of Acthar twice per week
干预措施: Acthar
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.
次要结局
- Ultrasound Grey Scale Synovial Hypertrophy score(Baseline to 2 Weeks)
- HAQ-DI(Baseline to 4 Weeks)