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 (FLEX-O)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,002
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
- •Patients will be male and female 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
- •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
- •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 897
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
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, 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 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
研究组 & 干预措施
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
干预措施: Placebo (Drug)
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
干预措施: Placebo (Drug)
120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
干预措施: LY2127399 (Drug)
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
干预措施: LY2127399 (Drug)
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
干预措施: LY2127399 (Drug)