CTRI/2014/07/004736招募中3 期
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
- 招募中
- 入组人数
- 2,671
- 试验地点
- 18
- 主要终点
- -Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
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 baricitinib RA studies being conducted in India are I4V-MC-JADX (CTRI/2013/12/004212) and I4V-MC-JADZ (CTRI/2013/12/004211).
The study provides for 2 years of additional treatment with baricitinib, but may be extended to allow for continued treatment for up to 5 years after evaluation of the safety profile of baricitinib.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Have completed the final active treatment in study JADZ with CTRI no.
- •(CTRI/2013/12/004211)(NCT01711359) or JADX (NCT01721057)with CTRI no.
- •(CTRI/2013/12/004212).
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.
结局指标
主要结局
-Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
时间窗: Time Frame: Baseline through 2 Years
次要结局
- -Proportion of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20, ACR50, and ACR70(Time Frame: Months 6, 12, 24, 36, 48, 54)
- -Proportion of Participants Maintaining a Disease Activity Score (DAS28) high-sensitivity C-Reactive Protein (hsCRP) ≤3.2, DAS28-Erythrocyte Sedimentation Rate (ESR) ≤3.2, DAS28-hsCRP 2.6 and DAS28-ESR 2.6(Time Frame: Months 6, 12, 24, 36, 48, 54)
- -Change from Baseline in modified Total Sharp Score (mTSS)(Time Frame: Baseline, Month 12, 24, 36, 48)
- -Proportion of Participants with mTSS change ≤0(Time Frame: Baseline, Months 12, 24, 36, 48)
- -Change from Baseline in Joint Space Narrowing(Time Frame: Baseline, Month 12, 24, 36, 48)
- -Change from Baseline in Duration of Morning Stiffness(Time Frame: Baseline, Month 12, 24, 36, 48, 54)
- -Change from Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores(Time Frame: Baseline, Months 30, 36, 54)
- -Proportion of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 and ≤2.8(Time Frame: Months 6, 12, 24, 36, 48, 54)
- -Proportion of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 and ≥0.3(Time Frame: Months 6, 12, 24, 36, 48, 54)
- -Change from Baseline in Bone Erosion Score(Time Frame: Baseline, Month 12, 24, 36, 48)
- -Healthcare Resource Utilization(Time Frame: Baseline through Months 30, 36, 54)
- -Proportion of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 and ≤3.3(Time Frame: Months 6, 12, 24, 36, 48, 54)
研究者
研究点 (18)
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