NCT02384538已完成2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects With Erosive Hand Osteoarthritis
AbbVie0 个研究点目标入组 132 人开始时间: 2015年3月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 主要终点
- Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 35 to
- •Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria
- •Must have radiographic evidence of erosive hand OA
- •Have one or more clinical signs and symptoms of active inflammation in at least three hand joints
- •Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.
排除标准
- •Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
- •Absolute neutrophil count < 2,000 per mm3
- •Diagnosis of one or more of the following:
- •Fibromyalgia,
- •Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
- •Psoriatic arthritis, psoriasis,
- •Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
- •Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia,
- •Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
- •Any uncontrolled medical illness or an unstable treatment or therapy.
- •Any reason that prohibits a subject to undergo an MRI.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
干预措施: Placebo for ABT-981 (Biological)
ABT-981
Experimental
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
干预措施: ABT-981 (Biological)
结局指标
主要结局
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
时间窗: Week 0 (Baseline), Week 16
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
次要结局
- Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
- Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
- Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
- Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
- Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
- Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit(Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26)
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