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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sprifermin (AS902330) 30 microgram (mcg) and placebo arms were planned, but did not enroll participants due to early study discontinuation.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Sprifermin (AS902330), 100 mcg
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Study Discontinuation                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat (ITT) analysis set included all participants randomly allocated to treatment.

Reporting Groups
  Description
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.

Baseline Measures
   Sprifermin (AS902330), 100 mcg 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 


  Outcome Measures

1.  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   [ Time Frame: 6 months post-MFx surgery ]

2.  Secondary:   Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery   [ Time Frame: Every 6 months up to 5 years beyond 6 months post-MFx surgery ]

3.  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)   [ Time Frame: Every 6 months up to 5 years ]

4.  Secondary:   Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score   [ Time Frame: Every 6 months up to 5 years ]

5.  Secondary:   Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score   [ Time Frame: Every 6 months up to 5 years ]

6.  Secondary:   Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score   [ Time Frame: Every 6 months up to 5 years ]

7.  Secondary:   Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score   [ Time Frame: Every 6 months up to 5 years ]

8.  Secondary:   Composition of the Refilled Cartilage Using T2 Mapping   [ Time Frame: Every 6 months up to 5 years ]

9.  Secondary:   Volume of the Refilled Cartilage   [ Time Frame: Every 6 months up to 5 years ]

10.  Secondary:   Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score   [ Time Frame: Every 6 months up to 5 years ]

11.  Secondary:   Six-minute Walk Test   [ Time Frame: Every 3 months up to 5 years beyond Month 6 post-MFx surgery ]

12.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Month 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.


  More Information

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 agreement is:
unchecked 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. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



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