The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
研究概览
简要总结
Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.
详细描述
Patients will be assigned to receive either Depo Medrol or Acthar treatment. A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment. At screening visit, inclusion and exclusion criteria will be assessed. If assessments have not been completed to verify these criteria, they will be performed at this visit. After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection. About 5 days after this first treatment injection, these assessment and samples will be performed again. About 5-6 weeks after first treatment injection, a final physician assessment will be performed. Patients will have the option of consenting to allow storage of samples for future research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis
- •on a stable regimen of medications
- •moderate to severe disease activity as measured by the Clinical Disease activity index (CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study
- •Patients must have at least one joint with the following features within 30 days of starting the study:
- •Joint must be tender
- •Joint must be swollen
- •Joint must have +2 or +3 doppler signal by ultrasound exam
- •Joint must have +2 or +3 gray scale synovitis by ultrasound exam e. Joint must be amenable to synovial biopsy.
- •f. Clinician assessing the joint must conclude, with a reasonable degree of certainty, that the swelling and tenderness observed in the joint is caused by rheumatoid arthritis, and not by another arthritic condition such as osteoarthritis, crystal arthritis, or infection.
排除标准
- •Patients on anti-coagulation therapy
- •Patients with an active infection
- •Patients receiving oral corticosteroids within 5 days of enrollment, or parenteral corticosteroids within 3 weeks of enrollment (unless deemed able to taper off medication under investigator oversight and supervision)
- •Patients with any history of joint infection
- •Patients with a history of tuberculosis or coccidioidomycosis
研究组 & 干预措施
Acthar
80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.
干预措施: Acthar Injectable Product (Drug)
Depo Medrol
40 milligrams of Depo Medrol will be injected intramuscularly one time
干预措施: Depo medrol (Drug)
结局指标
主要结局
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
时间窗: Samples collected about 30 minutes before first treatment injection and about five days after this first injection
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.
Initial degree of inflammation, as measured by a pathologist during histological assessment
时间窗: Samples collected about five days after first injection of treatment
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.
次要结局
- Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)(Assessments are performed about 5 days after first treatment injection)
- Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)(Assessments are performed about 1 hour before first treatment injection)
- Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)(Assessments are performed about 5-6 weeks after first treatment injection.)
- Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints(Assessments are performed about 1 hour before first treatment injection)
- Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints(Assessments are performed about 5 days after first treatment injection)
- Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment(Assessments are performed about 5-6 weeks after first treatment injection.)
- Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment(Assessments are performed about 5 days after first treatment injection)
- Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment(Assessments are performed about 5-6 weeks after first treatment injection.)
- Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints(Assessments are performed about 5-6 weeks after first treatment injection.)
- Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)(Assessments are performed about 1 hour before first treatment injection)
- Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment(Assessments are performed about 5 days after first treatment injection)
- Initial patient global health assessment measured by the patient (from 0=best to 100=worst)(Assessments are performed about 1 hour before first treatment injection)