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.

EMD Serono0 sites1 target enrollmentApril 2013

ConditionsCartilage Injury of Knee

InterventionsSprifermin (AS902330)Placebo

DrugsSprifermin (AS902330)Placebo

Overview

Phase: Phase 2
Intervention: Sprifermin (AS902330)
Conditions: Cartilage Injury of Knee
Sponsor: EMD Serono
Enrollment: 1
Primary Endpoint: 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
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

October 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EMD Serono

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Sprifermin (AS902330), 30 mcg

Intervention: Sprifermin (AS902330)

Sprifermin (AS902330), 100 mcg

Intervention: Sprifermin (AS902330)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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)