A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,877
- 试验地点
- 407
- 主要终点
- Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
研究概览
简要总结
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.
The study provides 7 years of additional treatment with baricitinib.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (NCT02265705)
排除标准
- •Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered
- •Have a known hypersensitivity to baricitinib or any component of this investigational product
- •Had investigational product permanently discontinued at any time during a previous baricitinib study
- •Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study
- •Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol
研究组 & 干预措施
4 milligram (mg) Baricitinib
4 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Baricitinib (Drug)
4 milligram (mg) Baricitinib
4 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Placebo (Drug)
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Baricitinib (Drug)
2 mg Baricitinib
2 mg Baricitinib administered orally once daily.
Participants received baricitinib doses according to the dose received at the completion of the originating study. Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Placebo (Drug)
2 mg Baricitinib Step-down
2 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Baricitinib (Drug)
4 mg Baricitinib Step-down
4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE
时间窗: Baseline through 84 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
次要结局
- Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response(Year 5 after entry into JADY)
- Change From Baseline of Originating Study in Joint Space Narrowing at Year 1(Baseline, Year 1)
- Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)(Baseline, Year 5)
- Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3(Year 5 after entry into JADY)
- Change From Baseline of Originating Study in Bone Erosion Score(Baseline, Year 5)
- Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20(Year 5 after entry into JADY)
- Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)(Baseline, Year 5)
- Percentage of Participants With mTSS Change ≤0(Year 5 after entry into JADY)
- Change From Baseline of Originating Study in Joint Space Narrowing at Year 5(Baseline, Year 5)
- Change From Baseline of Originating Study in Duration of Morning Stiffness(Baseline, Year 5)
- Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores(Baseline, Year 5)
- Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50(Year 5 after entry into JADY)
- Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6(Year 5 after entry into JADY)
- Change From Baseline of Originating Study in Joint Space Narrowing at Year 3(Baseline, Year 3)
- Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8(Year 5 after entry into JADY)
- Healthcare Resource Utilization(Baseline up to 84 Months)
- Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10(Years 5 after entry into JADY)
- Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8(Year 1 after entry into JADY)
- Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22(Year 5 after entry into JADY)
- Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3(Year 5 after entry into JADY)
- Percentage of Participants With Relapse Event During the 96-Week Step-Down Period(Week 0 through Week 96 of Step-down)