CTRI/2011/07/001867招募中3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,002
- 试验地点
- 20
- 主要终点
- Percentage of patients with American College of Rheumatology 20% response (ACR20)
研究概览
简要总结
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatmetn of rheumatoid arthritis while with or without background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.
This study is comprised of 2 periods:
Period 1 - 24 week blinded treatment
Period 2 - 48 week post treatment follow up
研究设计
- 研究类型
- Interventional
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years -Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm -If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
- •Woman must not be pregnant, breastfeeding, or become pregnant during the study -Age limit in India per Office of Drug Controller General India is 18 years to 65 years.
排除标准
- •Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks -Steroid injection or intravenous (iv) infusion in the last 6 weeks -Use of more than 10 mg/day of oral steroids in the last 6 weeks -Use of biologic DMARD concurrently or recently -History of a serious reaction to other biological DMARDs -Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks -Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study -Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA -Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years -Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines) -Hepatitis or human immunodeficiency virus (HIV) -A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months -Symptoms of herpes zoster or herpes simplex within the last month -Active or latent tuberculosis (TB) Current symptoms of a serious disorder or illness -Use of an investigational drug within the last month.
结局指标
主要结局
Percentage of patients with American College of Rheumatology 20% response (ACR20)
时间窗: 24 weeks
次要结局
- Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response(24 weeks)
- Mean percent improvement in ACR-N(24 weeks)
- Change from baseline to 24 weeks in Tender Joint Count (68 joint count)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Swollen Joint Count (66 joint count)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Patients Assessment of Pain (VAS)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Patients Global Assessment of Disease Activity (VAS)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Physicians Global Assessment of Disease Activity (VAS)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)(baseline, 24 weeks)
- Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP)(baseline, 24 weeks)
- Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response(24 weeks)
- Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores(baseline, 24 weeks)
- Time to ACR20 response(baseline through 24 weeks)
- Change from baseline to 24 weeks in absolute B cell counts(baseline, 24 weeks)
- Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels(baseline, 24 weeks)
- Population Pharmacokinetics (PK)(baseline through 24 weeks)
- Percentage of patients developing anti-LY2127399 antibodies(baseline through 24 Weeks)
- Change from baseline to 24 weeks in CRP(baseline, 24 weeks)
研究者
研究点 (20)
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