Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count
研究概览
简要总结
This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.
The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits.
Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet.
In this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Meet at least 4 of the 11 American College of Rheumatology (ACR) 1997 criteria for classification of SLE (see Appendix 1).OR meet the recent classification recommended by SLICC (Appendix 2) 6
- •≥3 swollen and tender joints on 2 examinations at least 2 weeks apart and no more than 8 weeks apart.
- •SLEDAI2K score ≥4 indicating active disease.
- •Documented positive ANA (≥1:80) and/or anti-dsDNA during course of SLE.
- •Men and women, at least 18 years of age. Women of childbearing potential must use adequate method(s) of contraception to avoid pregnancy throughout the study and for up to 2 months after last study drug dose. They must have a negative serum or urine pregnancy test prior to the start of study medication.
- •Background therapies allowed: antimalarials (dose constant for ≥ one month before study entry and during 16 weeks of trial), methotrexate (same criteria as for antimalarials), azathioprine (same criteria), mycophenolate (same criteria), leflunomide (same criteria).
- •During the screening period and for up to 6 weeks after randomization, a daily prednisone (or equivalent) regimen of up to 20 mg daily may be initiated to treat the moderate to severe disease activity present at screening. The initial steroid regimen is not required if investigators or patients believe that the risks would outweigh the potential benefits. Patients who do not take any glucocorticoids during the study will be included in the treatment groups and analysis.
- •*Steroids should be tapered to a target dose of no more than 10 mg/day of prednisone (or equivalent) by the end of Week 8 (Day 56). The steroid regimen should be tapered as quickly as safely possible. Prednisone dose requirements higher than 10 mg daily at the 8 week visit will cause the patient to be ruled a non-responder for the abatacept treatment arm.
排除标准
- •Subjects with active infection requiring oral or IV antibiotics within one month of first dose of study medication.
- •Subjects with BILAG A in any system outside the musculoskeletal system.
- •Subjects with positive quantiferon Gold test in the absence of treatment for tuberculosis.
- •Subjects with positive tests for active infection with hepatitis B or C during the past 6 months. Any confirmed positive test for HIV at any time prior to entry into this study.
- •Subjects with active glomerulonephritis (>3 g protein/24h and/or active urine sediment).
- •Subjects with active CNS disease.
- •Subjects with any other serious disease that would require immunosuppressive or parenteral anti-microbial therapy outside the study protocol.
- •Inability to self-administer subcutaneous injections, to comply with instructions, or to keep appointments for study visits.
- •Treatment with rituximab within the past 6 months (B cells must be detectable in peripheral blood at onset of treatment with study biologic), belimumab within the past 5 months, cyclophosphamide within the past 3 months.
- •Treatment with any other immunomodulatory biologic or cyclophosphamide during treatment with abatacept is not allowed.
- •Patients requiring >20 mg of prednisone daily.
- •Women who are pregnant or breast feeding.
- •Women of child bearing potential unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 2 months after last study drug.
- •Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection).
- •Any laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.
研究组 & 干预措施
Abatacept also known as Orencia also known as CTLA4Ig
32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks.
干预措施: abatacept also known as Orencia also known as CTLA4-Ig (Biological)
Placebo
32 SLE patients to be treated with subcutaneous placebo once a week for 16 weeks. Injection will be vehicle injected subcutaneously once a week for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count
时间窗: Baseline, 8 Weeks, 16 Weeks
Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.
次要结局
- Change in SLEDAI 2K(Baseline, 16 weeks)
- Change in the PGA Score(Baseline, 16 weeks)
- Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS)(Baseline, 16 weeks)
- Number of AEs and SAEs(16 weeks)
- Clinical Disease Activity Index (CDAI) Index Score(16 weeks)
- Number of Tender and Swollen Joints(baseline, 4, 8, 12 and 16 weeks)
- Change in the Total Sum of Tender and Swollen Joints(Baseline, 16 weeks)
- Number of Patients Who Tapered Prednisone to <10mg/Day(16 weeks)
- Mean Prednisone Dose (mg/Day)(Baseline, 8 and 16 weeks)