An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percent Change in Synovitis Scores From Baseline up to Week 16
研究概览
简要总结
This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and have moderately to severely active RA despite ongoing methotrexate (MTX) therapy
- •Have active RA defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms
- •Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (ESR) greater than 28 millimeters/hour (mm/hr)
- •Have a clinically inflamed joint suitable for synovial biopsy procedure
排除标准
- •Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 weeks prior to baseline
- •Have used oral corticosteroids at average daily doses of >10 milligrams/day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
- •Have received any parenteral corticosteroid injection within 6 weeks of baseline
- •Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX, hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline
研究组 & 干预措施
LY2127399
LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.
干预措施: LY2127399 (Drug)
结局指标
主要结局
Percent Change in Synovitis Scores From Baseline up to Week 16
时间窗: Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Percent Change in Synovial B Cell Mass From Baseline up to Week 16
时间窗: Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16
时间窗: Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
次要结局
- Percent Change in Various Cell Types in the Blood From Baseline up to Week 24(Baseline up to Week 24)