A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,147
- 试验地点
- 296
- 主要终点
- Percentage of Participants With Permanent Investigational Product Discontinuations
研究概览
简要总结
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
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
- Double (Participant, Investigator)
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
- •Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
排除标准
- 未提供
研究组 & 干预措施
4 mg Baricitinib
Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
干预措施: Placebo (Drug)
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
干预措施: Baricitinib (Drug)
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
干预措施: Placebo (Drug)
4 mg Baricitinib
Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
干预措施: Baricitinib (Drug)
Placebo to 2 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
干预措施: Baricitinib (Drug)
Placebo to 2 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
干预措施: Placebo (Drug)
Placebo to 4 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
干预措施: Baricitinib (Drug)
Placebo to 4 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Permanent Investigational Product Discontinuations
时间窗: Week 134
Percentage of participants with permanent investigational product discontinuations.
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Week 134
Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Percentage of Participants With Temporary Investigational Product Interruptions
时间窗: Week 134
Percentage of participants with temporary investigational product interruptions.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Week 134
Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
时间窗: Week 134
Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.
次要结局
- Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate(Baseline through Week 48)
- Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score(Week 48)
- Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response(Week 134)
- Change From Baseline in Tender Joint Count(Baseline through Week 48)
- Change From Baseline in Swollen Joint Count(Baseline trough Week 48)
- Change From Baseline in Worst Pain Numeric Rating Scale (NRS)(Baseline through Week 48)
- Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)(Week 48)
- Change From Baseline in Prednisone Dose(Baseline through Week 48)
- Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score(Baseline through Week 48)