NCT01689337终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Trial to Investigate the Efficacy and Safety of 30 mcg and 100 mcg AS902330 Given as One Cycle of Three Intra-articular Knee Injections Once a Week for Three Weeks as an Adjunct Treatment to Patients Following Microfracture Surgery for Cartilage Injury of the Knee.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 1
- 主要终点
- Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery
研究概览
简要总结
This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast growth factor-18 [rhFGF-18]) as an adjunct treatment to subjects following microfracture (MFx) surgery for cartilage injury of the knee.
Primary Objectives
- To evaluate the effect of Sprifermin (AS902330) intra-articular knee injections as adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in the target knee, as measured by gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) time constant 1 (T1) relaxation time at 6 months after MFx surgery
- To evaluate the safety profile of Sprifermin (AS902330) when administered intra-articular into the knee as adjunct to MFx surgery in subjects with cartilage injury of the knee
Secondary Objectives
- To further support the efficacy and safety of Sprifermin (AS902330) as an adjunct to MFx for cartilage injury repair through symptomatic outcomes and quantitative MRI measurement
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with candidature for MFx surgery on the femoral articular surfaces (medial or lateral condyles or trochlear groove), with intact subchondral bone
- •Subjects with moderate to severe pain in the target knee prior to surgery; average score greater than equal to (>=) 4.0 over 7 consecutive days on numeric rating scale of pain intensity (completed within 30 [+15] days before surgery)
- •Intraoperative inclusion criteria: Subjects with 1 or 2 focal chondral lesions per target knee, where peripheral debridement to healthy cartilage results in all of the following:
- •Each lesion has an area of >= 1 square centimeter (cm^2) and less than equal to (<=) 4 cm^2
- •Each lesion is <= 6 millimeter (mm) in depth, as measured from the surrounding subchondral plate
- •Arthroscopic confirmation that each non-osteochondritis dissecans (OCD) lesion is between International Cartilage Repair Society (ICRS) Grades I and III (D); a Grade III non-OCD lesion is equivalent to an Outerbridge Grade IV lesion with minimal subchondral bone loss
- •Other protocol-defined inclusion criteria could apply
排除标准
- •Subjects with prior marrow stimulation treatment of the target knee, that is, MFx, micro-drilling, abrasion chondroplasty or cartilage repair including, but not limited to, autologous chondrocyte implantation (ACI), matrix/membrane autologous chondrocyte implantation (MACI), or osteochondral transplantation (autologous or allogeneic)
- •Subjects with body mass index (BMI) of greater than 35 kilogram per square meter (kg/m^2) at screening
- •Malalignment of the target knee greater than 5 degrees as measured from the mechanical axis, as confirmed by alignment (long bone) X-ray images
- •Subjects with clinical and/or radiographic disease diagnosis of the target knee joint including, but not limited to the following: generalized osteoarthritis (OA), rheumatoid arthritis, or avascular necrosis
- •Subjects who have any contraindication to MRI or gadolinium-based or iodinated contrast agents according to the site's standard practice guidelines
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
Sprifermin (AS902330), 30 mcg
Experimental
干预措施: Sprifermin (AS902330) (Drug)
Sprifermin (AS902330), 100 mcg
Experimental
干预措施: Sprifermin (AS902330) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery
时间窗: 6 months post-MFx surgery
The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.
次要结局
- Composition of the Refilled Cartilage Using T2 Mapping(Every 6 months up to 5 years)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to Month 60)
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score(Every 6 months up to 5 years)
- Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery(Every 6 months up to 5 years beyond 6 months post-MFx surgery)
- Change From Baseline in Participant-reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scores for Pain and Activities of Daily Living (ADL)(Every 6 months up to 5 years)
- Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score(Every 6 months up to 5 years)
- Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score(Every 6 months up to 5 years)
- Six-minute Walk Test(Every 3 months up to 5 years beyond Month 6 post-MFx surgery)
- Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score(Every 6 months up to 5 years)
- Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score(Every 6 months up to 5 years)
- Volume of the Refilled Cartilage(Every 6 months up to 5 years)
研究者
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