NCT01443364已完成4 期
Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)
UCB Italy s.p.a.18 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2011年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 18
- 主要终点
- The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
研究概览
简要总结
The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
- •positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
- •active RA disease
- •subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
- •subject is naïve to RA related biologics
排除标准
- •a diagnosis of any other inflammatory arthritis
- •history of infected joint prosthesis, or other significant infection
- •known Tuberculosis (TB) disease or high risk of acquiring TB infection
研究组 & 干预措施
Certolizumab pegol
Experimental
干预措施: Certolizumab pegol (Biological)
结局指标
主要结局
The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 12 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 8 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 1 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 4 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 6 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
时间窗: From Baseline to Week 2 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system
次要结局
- Change From Baseline in the Synovial Fluid and Proliferation at Week 2(From Baseline to Week 2)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 1(From Baseline to Week 1)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 12(From Baseline to Week 12)
- Change From Baseline in the Cartilage Damage at Week 36(From Baseline to Week 36)
- Change From Baseline in the Cartilage Damage at Week 2(From Baseline to Week 2)
- Change From Baseline in the Bone Erosion at Week 4(From Baseline to Week 4)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 36(From Baseline to Week 36)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 24(From Baseline to Week 24)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 8(From Baseline to Week 8)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 12(From Baseline to Week 12)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 52(From Baseline to Week 52)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 8(From Baseline to Week 8)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 4(From Baseline to Week 4)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 52(From Baseline to Week 52)
- Change From Baseline in the Cartilage Damage at Week 52(From Baseline to Week 52)
- Change From Baseline in the Cartilage Damage at Week 12(From Baseline to Week 12)
- Change From Baseline in the Cartilage Damage at Week 6(From Baseline to Week 6)
- Change From Baseline in the Bone Erosion at Week 36(From Baseline to Week 36)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 6(From Baseline to Week 6)
- Change From Baseline in the Cartilage Damage at Week 8(From Baseline to Week 8)
- Change From Baseline in the Cartilage Damage at Week 4(From Baseline to Week 4)
- Change From Baseline in the Bone Erosion at Week 24(From Baseline to Week 24)
- Change From Baseline in the Bone Erosion at Week 12(From Baseline to Week 12)
- Change From Baseline in the Bone Erosion at Week 6(From Baseline to Week 6)
- Change From Baseline in the Bone Erosion at Week 2(From Baseline to Week 2)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52(From Baseline to Week 52)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1(From Baseline to Week 1)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 6(From Baseline to Week 6)
- Change From Baseline in the Synovial Fluid and Proliferation at Week 4(From Baseline to Week 4)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 36(From Baseline to Week 36)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 24(From Baseline to Week 24)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 1(From Baseline to Week 1)
- Change From Baseline in the Bone Erosion at Week 1(From Baseline to Week 1)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36(From Baseline to Week 36)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6(From Baseline to Week 6)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2(From Baseline to Week 2)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12(From Baseline to Week 12)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6(From Baseline to Week 6)
- Change From Baseline in the Doppler Signal and Blood Flow at Week 2(From Baseline to Week 2)
- Change From Baseline in the Cartilage Damage at Week 24(From Baseline to Week 24)
- Change From Baseline in the Cartilage Damage at Week 1(From Baseline to Week 1)
- Change From Baseline in the Bone Erosion at Week 52(From Baseline to Week 52)
- Change From Baseline in the Bone Erosion at Week 8(From Baseline to Week 8)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24(From Baseline to Week 24)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8(From Baseline to Week 8)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4(From Baseline to Week 4)
- Synovial Fluid and Proliferation at Week 36(Week 36)
- Synovial Fluid and Proliferation at Week 4(Week 4)
- Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12(From Baseline to Week 12)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24(From Baseline to Week 24)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4(From Baseline to Week 4)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1(From Baseline to Week 1)
- Synovial Fluid and Proliferation at Week 52(Week 52)
- Doppler Signal and Blood Flow at Week 6(Week 6)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52(From Baseline to Week 52)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36(From Baseline to Week 36)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8(From Baseline to Week 8)
- Synovial Fluid and Proliferation at Week 6(Week 6)
- Synovial Fluid and Proliferation at Week 12(Week 12)
- Synovial Fluid and Proliferation at Week 8(Week 8)
- Doppler Signal and Blood Flow at Week 36(Week 36)
- Doppler Signal and Blood Flow at Week 2(Week 2)
- Cartilage Damage at Week 0(Week 0 (Baseline))
- Bone Erosion at Week 8(Week 8)
- Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2(From Baseline to Week 2)
- Synovial Fluid and Proliferation at Week 24(Week 24)
- Synovial Fluid and Proliferation at Week 2(Week 2)
- Synovial Fluid and Proliferation at Week 1(Week 1)
- Doppler Signal and Blood Flow at Week 52(Week 52)
- Doppler Signal and Blood Flow at Week 24(Week 24)
- Bone Erosion at Week 6(Week 6)
- Synovial Fluid and Proliferation at Week 0(Week 0 (Baseline))
- Doppler Signal and Blood Flow at Week 12(Week 12)
- Cartilage Damage at Week 1(Week 1)
- Bone Erosion at Week 52(Week 52)
- Bone Erosion at Week 2(Week 2)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52(Week 52)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8(Week 8)
- Doppler Signal and Blood Flow at Week 8(Week 8)
- Doppler Signal and Blood Flow at Week 1(Week 1)
- Doppler Signal and Blood Flow at Week 0(Week 0 (Baseline))
- Cartilage Damage at Week 36(Week 36)
- Cartilage Damage at Week 12(Week 12)
- Bone Erosion at Week 24(Week 24)
- Bone Erosion at Week 4(Week 4)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2(Week 2)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36(Week 36)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4(Week 4)
- Doppler Signal and Blood Flow at Week 4(Week 4)
- Cartilage Damage at Week 52(Week 52)
- Bone Erosion at Week 12(Week 12)
- Bone Erosion at Week 0(Week 0 (Baseline))
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1(Week 1)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12(Week 12)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6(Week 6)
- Cartilage Damage at Week 24(Week 24)
- Cartilage Damage at Week 8(Week 8)
- Cartilage Damage at Week 6(Week 6)
- Cartilage Damage at Week 4(Week 4)
- Cartilage Damage at Week 2(Week 2)
- Bone Erosion at Week 36(Week 36)
- Bone Erosion at Week 1(Week 1)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52(Week 52)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12(Week 12)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4(Week 4)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0(Week 0 (Baseline))
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36(Week 36)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24(Week 24)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8(Week 8)
- Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6(Week 6)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24(Week 24)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2(Week 2)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1(Week 1)
- Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0(Week 0 (Baseline))
研究者
研究点 (18)
Loading locations...
相似试验
已完成
3 期
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisNCT00753454UCB Pharma168
已完成
4 期
A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AUAxial Spondyloarthritis (axSpA)Anterior Uveitis (AU)NCT03020992UCB Biopharma SRL89
已完成
1 期
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid ArthritisRheumatoid ArthritisNCT04740814UCB Biopharma SRL33
已完成
2 期
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab PegolCrohn's DiseaseNCT01190410UCB Pharma16
已完成
3 期
Pediatric Arthritis Study of Certolizumab PegolPolyarticular-course Juvenile Idiopathic Arthritis (JIA)NCT01550003UCB BIOSCIENCES GmbH193