A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,820
- 主要终点
- Percentage of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
详细描述
This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study). The maximum duration of participation in this study is 208 weeks, followed by approximately 16 weeks of safety and efficacy follow-up after the administration of the final study agent injection of sirukumab. Participant safety will be monitored throughout the study.
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
- •Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
- •Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
排除标准
- •Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
- •Is pregnant
- •Has active diverticulitis
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Sirukumab 100 mg
干预措施: Sirukumab 100 mg (Drug)
Sirukumab 50 mg / placebo
干预措施: Sirukumab 50 mg (Drug)
Sirukumab 50 mg / placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: From baseline of this LTE study up to 4.3 years
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
时间窗: From baseline of this LTE study up to 4.3 years
MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion.
Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events
时间窗: From baseline of this LTE study up to 4.3 years
Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.
Percentage of Participants With Malignancies
时间窗: From baseline of this LTE study up to 4.3 years
Percentage of participants with one or more malignancy was reported.
Percentage of Participants With Serious Infections
时间窗: From baseline of this LTE study up to 4.3 years
Percentage of participants with one or more serious infections was reported.
Percentage of Participants With Gastrointestinal (GI) Perforations
时间窗: From baseline of this LTE study up to 4.3 years
Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
Percentage of Participants With Hepatobiliary Abnormalities
时间窗: From baseline of this LTE study up to 4.3 years
Percentage of participants with hepatobiliary abnormalities was reported.
次要结局
- Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Toxicity Grade 4 Decrease in Platelets(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline(From baseline of primary studies through end of this LTE study (Approximately 5.3 years))
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260(Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260(Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260(Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260(Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260(Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260(Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)
- Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260(Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260)