EUCTR2010-022205-17-LT进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients aged =18 years of age with a diagnosis of moderately to severely active adult onset RA
- •Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
- •Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
- •At least 8 tender and swollen joints
- •At least one erosion of a hand or foot joint observed on an X-ray
- •An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
- •Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody
- •Woman must not be pregnant, breastfeeding, or become pregnant during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 886
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
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
- •History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
- •History of a serious reaction to other biological DMARDs
- •History of the use of rituximab or other B cell therapy
- •Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
- •Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
- •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, Crohn's 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 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
- •History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
研究者
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