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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001431-31 | EudraCT Number |
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The study was discontinued due to low recruitment.
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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
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sprifermin (AS902330), 30 mcg | Experimental |
| |
| Sprifermin (AS902330), 100 mcg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sprifermin (AS902330) | Drug | Sprifermin (AS902330) will be administered at a dose of 30 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 6 months post-MFx surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 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. | Every 6 months up to 5 years beyond 6 months post-MFx surgery |
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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:
Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany | Study Director |
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Sprifermin (AS902330) 30 microgram (mcg) and placebo arms were planned, but did not enroll participants due to early study discontinuation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sprifermin (AS902330), 100 mcg | Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sprifermin (AS902330) | Drug | Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery. |
|
| Placebo | Drug | Placebo matched to Sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 weeks, starting from 2 weeks after 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) | The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline. | Every 6 months up to 5 years |
| Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score | The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline. | Every 6 months up to 5 years |
| Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score | Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline. | Every 6 months up to 5 years |
| Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score | The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants' actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline. | Every 6 months up to 5 years |
| Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score | The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline. | Every 6 months up to 5 years |
| Composition of the Refilled Cartilage Using T2 Mapping | The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported. | Every 6 months up to 5 years |
| Volume of the Refilled Cartilage | Volume of the refilled cartilage was to be measured by MRI. | Every 6 months up to 5 years |
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score | The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures. | Every 6 months up to 5 years |
| Six-minute Walk Test | Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported. | Every 3 months up to 5 years beyond Month 6 post-MFx surgery |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | Baseline up to Month 60 |
| COMPLETED |
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| NOT COMPLETED |
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Intention-to-treat (ITT) analysis set included all participants randomly allocated to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sprifermin (AS902330), 100 mcg | Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | 6 months post-MFx surgery |
|
| |||||||||||||||||||
| Secondary | Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 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. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years beyond 6 months post-MFx surgery |
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| |||||||||||||||||||
| Secondary | 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) | The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
| ||||||||||||||||||||
| Secondary | Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score | The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
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| Secondary | Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score | Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score | The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants' actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score | The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
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| Secondary | Composition of the Refilled Cartilage Using T2 Mapping | The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
| |||||||||||||||||||
| Secondary | Volume of the Refilled Cartilage | Volume of the refilled cartilage was to be measured by MRI. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
| |||||||||||||||||||
| Secondary | Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score | The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 6 months up to 5 years |
|
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| Secondary | Six-minute Walk Test | Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported. | Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment. | Posted | Every 3 months up to 5 years beyond Month 6 post-MFx surgery |
|
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. | The safety analysis set included all participants who received at least 1 dose of trial drug. | Posted | Number | participants | Baseline up to Month 60 |
|
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Up to 6 months
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sprifermin (AS902330), 100 mcg | Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery. | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Streptococcal pharyngitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
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| Knee swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can with reasonable grounds require changes to the communication which do not change the scientific statement or neutrality of the communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| C113569 | fibroblast growth factor 18 |
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