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A Multicenter Trial of Sprifermin (AS902330 [Recombinant Human Fibroblast Growth Factor-18]) or Placebo After Microfracture Surgery for Cartilage Injury of the Knee

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ClinicalTrials.gov Identifier: NCT01689337
Recruitment Status : Terminated (The study was discontinued due to low recruitment.)
First Posted : September 21, 2012
Results First Posted : August 31, 2015
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cartilage Injury of Knee
Interventions Drug: Sprifermin (AS902330)
Drug: Placebo
Enrollment 1

Recruitment Details  
Pre-assignment Details Sprifermin (AS902330) 30 microgram (mcg) and placebo arms were planned, but did not enroll participants due to early study discontinuation.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Study Discontinuation             1
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) analysis set included all participants randomly allocated to treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 6 months post-MFx surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery
Hide Description 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.
Time Frame Every 6 months up to 5 years beyond 6 months post-MFx surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title AS902330, 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Composition of the Refilled Cartilage Using T2 Mapping
Hide Description 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.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Volume of the Refilled Cartilage
Hide Description Volume of the refilled cartilage was to be measured by MRI.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score
Hide Description The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures.
Time Frame Every 6 months up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Six-minute Walk Test
Hide Description 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.
Time Frame Every 3 months up to 5 years beyond Month 6 post-MFx surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to Month 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least 1 dose of trial drug.
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description:
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 MFx surgery.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
Adverse Events 1
Serious Adverse Events 0
Time Frame Up to 6 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Sprifermin (AS902330), 100 mcg
Hide Arm/Group Description 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.
All-Cause Mortality
Sprifermin (AS902330), 100 mcg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sprifermin (AS902330), 100 mcg
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sprifermin (AS902330), 100 mcg
Affected / at Risk (%)
Total   1/1 (100.00%) 
General disorders   
Pyrexia * 1  1/1 (100.00%) 
Infections and infestations   
Streptococcal pharyngitis * 1  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders   
Knee swelling * 1  1/1 (100.00%) 
Nervous system disorders   
Syncope * 1  1/1 (100.00%) 
Psychiatric disorders   
Panic attack * 1  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders   
Nasal congestion * 1  1/1 (100.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 16.0
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01689337     History of Changes
Other Study ID Numbers: EMR700692-007
2012-001431-31 ( EudraCT Number )
First Submitted: September 17, 2012
First Posted: September 21, 2012
Results First Submitted: July 8, 2015
Results First Posted: August 31, 2015
Last Update Posted: January 13, 2017