A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 172
- 试验地点
- 39
- 主要终点
- British Isles Lupus Assessment Group 2004 (BILAG 2004)
研究概览
简要总结
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE).
The doctor will assign eligible patients to one of two groups (like flipping a coin).
Participants will receive the treatment assigned to their group for 24 weeks:
- Acthar Gel
- Placebo Gel, which looks like Acthar Gel, but has no medicine in it.
The doctor or his staff will take measurements and ask questions to:
- see how well the gel is working
- see how safe it is for patients with SLE
详细描述
This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
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
- Double (Participant, Investigator)
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
- •To be eligible to participate in this trial, a patient must:
- •Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
- •Have active SLE
- •Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
- •Have a documented history or screening result of
- •positive antinuclear antibody (ANA), OR
- •elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
- •Have been on prednisone (or prednisone equivalent) before the screening visit:
- •at least 8 weeks, and
- •at a stable dose of 7.5 mg to 30 mg for at least 4 weeks
- •Exclusion criteria:
- •A patient is not eligible to participate if he/she:
- •Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or porcine products
- •Has active lupus nephritis
- •Has active central nervous system (CNS) manifestations of SLE
排除标准
- 未提供
研究组 & 干预措施
Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
干预措施: Acthar Gel (Drug)
Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
干预措施: Placebo Gel (Drug)
结局指标
主要结局
British Isles Lupus Assessment Group 2004 (BILAG 2004)
时间窗: Baseline, Week 16, Week 24
BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
时间窗: Week 16, Week 24
The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
Physician's Global Assessment (PGA)
时间窗: Baseline, Week 16, Week 24
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
次要结局
- Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16(Week 16)
- Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score(at Baseline and Weeks 4, 8, and 16)
- Mean Number of Swollen or Tender Joints on the 28-Joint Count(at Baseline and at Weeks 4, 8, 12 and 16)
- Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24(Week 20, Week 24)