A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 1,648
- 主要终点
- American College of Rheumatology 20% (ACR20) Response at Week 12
研究概览
简要总结
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
详细描述
The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.
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
- •Adult patient with established moderate to severe rheumatoid arthritis
排除标准
- •All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- •Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
研究组 & 干预措施
Certolizumab pegol (CZP)
干预措施: Certolizumab pegol (CZP) (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
American College of Rheumatology 20% (ACR20) Response at Week 12
时间窗: Baseline, Week 12
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
次要结局
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.(Baseline, Week 12)
- American College of Rheumatology 50% (ACR50) Response at Week 12(Baseline, Week 12)
- American College of Rheumatology 70% (ACR70) Response at Week 12.(Baseline, Week 12)
- Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12(Baseline, Week 12)
- Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12(Baseline, Week 12)
- Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12(Baseline, Week 12)
- Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12(Baseline, Week 12)
- DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12(Week 12)
- SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12(Week 12)
- CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12(Week 12)
- Change From Baseline in Tender Joint Count (TJC) at Week 12(Baseline, Week 12)
- Change From Baseline in Swollen Joint Count (SJC) at Week 12(Baseline, Week 12)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12(Baseline, Week 12)
- Change From Baseline in C-reactive Protein (CRP) at Week 12(Baseline, Week 12)
- Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12(Baseline, Week 12)
- Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12(Baseline, Week 12)
- Time to Sustained American College of Rheumatology 20% (ACR20) Response(Baseline up to Week 12)
- European League Against Rheumatism (EULAR) Response at Week 12(Baseline, Week 12)
- American College of Rheumatology 20% (ACR20) Response at Week 28(Baseline, Week 28)
- American College of Rheumatology 50% (ACR50) Response at Week 28(Baseline, Week 28)
- American College of Rheumatology 70% (ACR70) Response at Week 28(Baseline, Week 28)
- Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28(Baseline, Week 28)
- Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28(Baseline, Week 28)
- Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28(Baseline, Week 28)
- DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28(Week 28)
- SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28(Week 28)
- CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28(Week 28)
- Change From Baseline in Tender Joint Count (TJC) at Week 28(Baseline, Week 28)
- Change From Baseline in Swollen Joint Count (SJC) at Week 28(Baseline, Week 28)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28(Baseline, Week 28)
- Change From Baseline in C-reactive Protein (CRP) at Week 28(Baseline, Week 28)
- Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28(Baseline, Week 28)
- Change From Baseline in Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28(Baseline, Week 28)
- Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28(Baseline, Week 28)