A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
研究概览
简要总结
A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.
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
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
- •Body Mass Index (BMI) 18-34 kg/m2
- •One or more clinical signs and symptoms of active inflammation in the index knee
排除标准
- •History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
- •History of anaphylactic reaction to any agent
- •Significant trauma or surgery to the index knee
- •Severe knee malalignment
- •Any uncontrolled medical illness or an unstable treatment or therapy
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
ABT-981 high dose
200 mg ABT-981 SC E2W
干预措施: ABT-981 (Biological)
ABT-981 medium dose
100 mg ABT-981 SC E2W
干预措施: ABT-981 (Biological)
ABT-981 low dose
25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)
干预措施: ABT-981 (Biological)
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
时间窗: Baseline, Week 16
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
时间窗: Baseline, Week 26
Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.
Change From Baseline in Effusion Volume of the Index Knee at Week 26
时间窗: Baseline, Week 26
Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26
时间窗: Baseline, Week 26
Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \> 66% of maximum estimated distention (3).
次要结局
- Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26(Baseline, Week 26)
- Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52(Baseline, Week 52)
- Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16(Baseline, Week 16)
- Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26(Baseline, Week 26)
- Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52(Baseline, Week 52)
- Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26(Baseline, Week 26)
- Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52(Baseline, Week 52)
- Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16(Baseline, Week 16)
- Change From Baseline in Index Knee ICOAP Scores at Week 26(Baseline, Week 26)
- Change From Baseline in Index Knee ICOAP Scores at Week 52(Baseline, Week 52)
- Change From Baseline In Index Knee Pain Intensity at Week 16(Baseline, Week 16)
- Change From Baseline In Index Knee Pain Intensity at Week 26(Baseline, Week 26)
- Change From Baseline In Index Knee Pain Intensity at Week 52(Baseline, Week 52)
- Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16(Baseline, Week 16)
- Change From Baseline in PGA of Arthritis of the Index Knee at Week 26(Baseline, Week 26)
- Change From Baseline in PGA of Arthritis of the Index Knee at Week 52(Baseline, Week 52)
- Change From Baseline in Cartilage Volume of the Index Knee at Week 26(Baseline, Week 26)
- Change From Baseline in Cartilage Volume of the Index Knee at Week 52(Baseline, Week 52)
- Change From Baseline in Cartilage Thickness of the Index Knee at Week 26(Baseline, Week 26)
- Change From Baseline in Cartilage Thickness of the Index Knee at Week 52(Baseline, Week 52)
- Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16(Week 16)
- Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26(Week 26)
- Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52(Week 52)