Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 17
- 主要终点
- OMERACT-OARSI Responder Rate at 39 Weeks
研究概览
简要总结
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
详细描述
Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee
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
- Double (Participant, Outcomes Assessor)
盲法说明
Study subjects and the Outcomes Assessor are blinded to the study treatment.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.
- •Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.
排除标准
- •Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
研究组 & 干预措施
Cingal
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
干预措施: Cingal (Combination Product)
Monovisc
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
干预措施: Monovisc (Device)
Triamcinolone Hexacetonide (TH)
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
干预措施: Triamcinolone Hexacetonide (Drug)
结局指标
主要结局
OMERACT-OARSI Responder Rate at 39 Weeks
时间窗: 39 weeks
The post treatment Responder Rate at 39 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
次要结局
- Change From Baseline in Total WOMAC Score at 39 Weeks(39 Weeks)
- Change From Baseline in WOMAC Pain Score at 39 Weeks(39 Weeks)
- Change From Baseline in Patient Global Assessment at 39 Weeks(39 Weeks)
- Change From Baseline in Evaluator Global Assessment at 39 Weeks(39 Weeks)
- The Usage of Rescue Medication (Acetaminophen) at Week 39(39 Weeks)
- Change From Baseline in WOMAC Physical Function Score at 39 Weeks(39 Weeks)
- Change From Baseline in WOMAC Stiffness Score at 39 Weeks(39 Weeks)