EUCTR2013-003467-60-IT进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient must have radiographic evidence of knee osteoarthritis in the medial compartment of the index knee with Kellgren-Lawrence Grade 2 or 3 (with minimum 2 mm joint space width) during Screening as evaluated by a qualified central imaging reader. Prior radiographs taken no more than 3 months before Study Day 1 with Synaflexer™ will be submitted for centralized eligibility reading.
- •2. Patient must have either constant or intermittent index knee pain at least 14 days over the past 30 days at screening. The intensity of index knee pain is between 4 and 8 out of 10, inclusive, at the initial Screening Visit and Study Day 1. The intensity of index knee pain is recorded as the average pain during the past week.
- •3.Patient has one or more clinical signs and symptoms of active inflammation in the index knee (localized pain, joint stiffness, swelling and effusion) during Screening and Study Day 1.
- •4.Presence of synovitis in the index knee confirmed by ultrasound during Screening.
- •5.Patient discontinued analgesics, non-steroidal anti-inflammatory drugs and nutraceuticals (e.g., glucosamine, chondroitin sulfate, shark cartilage, diacerein, soy extract) at least 7 days prior to first dose of study drug until after Week 26 MRI visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1.History of allergic reaction or significant sensitivity to any constituents of the study drug, history of anaphylactic reaction to any agent (e.g., food products or bee stings) or history of a major reaction to any IgG-containing product.
- •2.Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 6 months of Screening.
- •3.Kellgren-Lawrence Grade 1 or 4 in the index knee.
- •4.Severe knee malalignment, either greater than 2° in varus; or greater than 5° in valgus angulation in the index knee.
- •5.Diagnosis of one or more of the following:
- •a.Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthropathy, gout, or pseudogout (defined as acute episodic attacks of swollen , painful joints in a patient with X-Ray chondrocalcinosis or CPPD crystals);
- •b.Other chronic painful syndromes (such as Paget's disease and fibromyalgia) and clinically significant non-articular musculoskeletal pain that could interfere with assessment of pain at the index knee.
- •6. History or evidence of active tuberculosis (TB)
- •7. Any uncontrolled medical illness or unstable treatment ot therapy.
研究者
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