A Multicenter, Prospective, Open-Label Study of the Safety and Efficacy of 6 mL Synvisc-One ® (Hylan G F 20) in Indian Patients With Symptomatic Osteoarthritis of the Knee(s) After Initial and Repeat Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 主要终点
- Change From Baseline in WOMAC A1 Subscore at Week 26
研究概览
简要总结
Primary Objective:
To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).
Secondary Objective:
To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
详细描述
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participant aged 30 years or older, with active lifestyle.
- •The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations.
- •The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL] Grade I-III), predominant in the tibiofemoral compartment.
- •WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee.
- •Participants with bilateral disease may be included in the study with the below strict conditions:
- •Only one knee included in the efficacy assessment and considered the target knee (the worst knee by the WOMAC A1 pain scale should be selected). The selected knee must meet the inclusion and exclusion criteria.
- •The non-target knee may also be treated with Synvisc-One and does not need to meet the KL grade knee specific inclusion criteria described above. The other criteria do apply.
- •If female, must had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must had been surgically sterile or postmenopausal (as documented in the medical history) for at least 1 year.
排除标准
- •Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
- •Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, or chondrocalcinosis).
- •History of sepsis in any joint or any clinical concern for a subacute infectious process in the target joint.
- •History of surgery in the target knee.
- •Planned surgery on any lower extremity joint.
- •Clinically significant venous or lymphatic stasis present in the leg(s).
- •Clinically apparent tense effusion or inflammation at the target knee.
- •Skin disease or infection in the area of the injection site.
- •Any musculoskeletal condition that would impede measurement of efficacy at the target knee.
- •Pregnant or lactating women.
- •Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection.
- •Treatment with any hyaluronic acid (HA) or derivatives in the previous 6 months.
- •Treatment with IA steroids in the previous 3 months.
- •Any contraindication to IA injection, eg, anticoagulant therapy or clinical concern for potential coagulopathy (eg, liver disease).
- •Any significant medical condition (eg, significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors (eg, planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Synvisc-One
Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore [measurement of pain while walking on flat surface] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment).
干预措施: Synvisc-One (Drug)
结局指标
主要结局
Change From Baseline in WOMAC A1 Subscore at Week 26
时间窗: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
次要结局
- Change From Baseline in WOMAC A1 Subscore at Week 52(Baseline, Week 52 (missing data imputed by LOCF))
- Change From Baseline in WOMAC B Score at Week 52(Baseline, Week 52 (missing data imputed by LOCF))
- Change From Baseline in WOMAC C Score at Week 52(Baseline, Week 52 (missing data imputed by LOCF))
- Change From Baseline in WOMAC A Score at Week 52(Baseline, Week 52 (missing data imputed by LOCF))
- 12-Item Short Form Health Survey (SF-12)(Baseline, Week 26, 52)
- Patient Global Assessment (PTGA) Score at Week 52(Week 52 (missing data imputed by LOCF))
- Clinician Observer Global Assessment (COGA) Score at Week 52(Week 52 (missing data imputed by LOCF).)
- Time Between Initial and Repeat Synvisc-One Treatment(Baseline up to Week 52)
- Change From Baseline in WOMAC B Score After Repeat Injection(Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF))
- Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52(Baseline up to Week 52)
- Change From Baseline in WOMAC A1 Subscore After Repeat Injection(Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF))
- Change From Baseline in WOMAC A Score After Repeat Injection(Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF))
- Change From Baseline in WOMAC C Score After Repeat Injection(Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF))