Isolated Cartilage Injury of the Knee
Conditions
Keywords
Knee cartilage injury, fibroblast growth factor 18, FGF18
Brief summary
Several people all over the world suffer from cartilage injuries in the knee. Symptoms include pain, joint swelling, and loss of function. Without repair, cartilage injury may ultimately lead to osteoarthritis (OA). Natural healing is poor, and to date treatment is available only for deep cartilage defects involving also the underlying bone. A promising candidate for drug treatment of cartilage injury is sprifermin (AS902330), a recombinant form of the human fibroblast growth factor (FGF) 18. So far, the drug has been used in subjects with different stages of knee OA in two ongoing studies without emerging safety issues following single and multiple intra-articular injections of ascending doses. However, OA represents late-stage cartilage injury, where repair might be difficult due to diffuse damage, reduced responsiveness of the cartilage, and/or the involvement of other joint structures. This clinical trial is meant to provide the proof of concept and to identify an efficacious dose of sprifermin (AS902330) for the treatment of adult subjects with acute cartilage injuries of the knee. The first subject for this trial was treated on the 19th of April 2010.
Interventions
DRUGSprifermin (AS902330) 10 mcg
Sprifermin (AS902330) will be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
DRUGSprifermin (AS902330) 30 mcg
Sprifermin (AS902330) will be administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
DRUGSprifermin (AS902330) 100 mcg
Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
OTHERPlacebo
Placebo matched to sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 consecutive weeks.
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Acute cartilage lesion of ICRS grade 2 to 4 at the femoral condyle of the knee (= target knee) * Age: 18 to 45 years * Sex: male or female. Women of childbearing potential (that is, all female subjects after puberty unless they are post-menopausal for at least 2 years or surgically sterile) must have negative serum and urine pregnancy tests at screening and Visit 1, respectively, and must use a highly effective method of contraception. * History of pain and effusion of the target knee post-injury * Injury within 4 to 12 weeks prior to 1st treatment with investigational medicinal product (IMP) * Written informed consent prior to any trial-related activity
Exclusion criteria
* Personal medical history of osteoarthritis OA in either knee * Any previous surgery on the target knee * History of swelling of the target knee along with pain on weight-bearing, or arthroscopy for diagnostic purposes during the 12 months preceding injury * Corticosteroid (intra-articular) injection into the target knee during the preceding 12 months * Any other intra-articular injection into the target knee during the preceding 3 months * Any concurrent injury (for example, arthrolith, anterior cruciate ligament rupture, meniscus tear) of the target knee requiring surgical intervention * OA or any pre-existing cartilage damage in the target knee, as revealed by MRI * Legal incapacity or limited legal capacity * Subjects who are imprisoned or institutionalized by regulatory or court order * Pregnancy or lactation * Participation in another clinical trial within the past 30 days * Any condition or findings in the medical history or in the pre-trial assessments that in the opinion of the Investigator constitutes a risk or contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation * Known hypersensitivity to the trial treatment or diluents * Significant renal or hepatic impairment, as indicated by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) greater than (\>) 3 times the upper limit of normal (ULN); total bilirubin \>1.5 times ULN (except in case of Gilbert's syndrome); creatinine \>1.5 times ULN; hemoglobin less than (\<5.5) millimole per liter (mmol/L), white blood cell count (WBC) \<2.5 \* 10\^9 per liter, or platelets \<75 \*10\^9 per liter) * Any suspicion of intra-articular infection * Any known active infections that may compromise the immune system such as human immunodeficiency virus (HIV), Hepatitis B or C infection * History of sarcoma and/or of other active malignancy within five years, except adequately treated basal cell or squamous cell carcinoma of the skin * Open growth plate, as revealed by MRI * Diagnostic arthroscopy after injury and within 4 weeks prior to treatment start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Cartilage Defect Volume at Month 12 | Baseline, Month 12 | Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)\*100/volume at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Baseline, Months 3 and 6 | Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: (\[volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively\]\*100)/volume or thickness at baseline. |
| Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively. |
| Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively. |
| Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | Months 3 (M3), 6 (M6) and 12 (M12) | MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair \[DDR\] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone \[IBZ\] score 0 (\> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue \[SRT\] score 0 (\>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue \[StRT\] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity \[T2\] Mapping Sequence \[T2MS\] and Hi-Res Sagittal Pharmacodynamic Sequence \[Hi-Res SPS\] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair. |
| Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Baseline, Month 12 | The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes. |
| Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Month 12 | The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 \[patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral\], synovitis, and effusion) scores at Month 12 were reported. |
| Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Baseline, Months 6 and 12 | The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury. |
| Number of Participants With Global Evaluation of Treatment Benefit | Months 3, 6 and 12 | Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent. |
| Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Baseline up to Month 12 | An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body. |
| Number of Participants With Acute Inflammatory Reactions | Baseline up to Month 12 | Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection. |
| Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 | Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sprifermin (AS902330) 10 mcg Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks. | 20 |
| Sprifermin (AS902330) 30 mcg Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks. | 18 |
| Sprifermin (AS902330) 100 mcg Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks. | 18 |
| Placebo Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks. | 18 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 0 |
| Overall Study | Other | 0 | 2 | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Sprifermin (AS902330) 10 mcg | Sprifermin (AS902330) 30 mcg | Sprifermin (AS902330) 100 mcg | Placebo |
|---|---|---|---|---|---|
| Age, Customized Greater than or equal to (>=) 40 years | 13 participants | 4 participants | 3 participants | 4 participants | 2 participants |
| Age, Customized Less than (<) 40 years | 61 participants | 16 participants | 15 participants | 14 participants | 16 participants |
| Sex: Female, Male Female | 20 Participants | 5 Participants | 5 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 54 Participants | 15 Participants | 13 Participants | 11 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 19 | 11 / 18 | 13 / 18 | 15 / 19 |
| serious Total, serious adverse events | 1 / 19 | 0 / 18 | 2 / 18 | 0 / 19 |
Outcome results
Primary
Percent Change From Baseline in Cartilage Defect Volume at Month 12
Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)\*100/volume at baseline.
Time frame: Baseline, Month 12
Population: The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Percent Change From Baseline in Cartilage Defect Volume at Month 12 | -14.4 Percent change | Standard Deviation 27.17 |
| Sprifermin (AS902330) 30 mcg | Percent Change From Baseline in Cartilage Defect Volume at Month 12 | -17.8 Percent change | Standard Deviation 29.24 |
| Sprifermin (AS902330) 100 mcg | Percent Change From Baseline in Cartilage Defect Volume at Month 12 | -12.0 Percent change | Standard Deviation 34.8 |
| Placebo | Percent Change From Baseline in Cartilage Defect Volume at Month 12 | -17.0 Percent change | Standard Deviation 26.65 |
Secondary
Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12
The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.
Time frame: Baseline, Month 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Baseline (n=19, 16, 17, 17) | 1.68 units on a scale | Standard Deviation 2.262 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Change at Month 12(n=16, 14, 15, 16) | -0.69 units on a scale | Standard Deviation 2.089 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Baseline (n=19, 16, 17, 17) | 0.37 units on a scale | Standard Deviation 0.831 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Change at Month12 (n=16, 14, 15, 16) | -0.06 units on a scale | Standard Deviation 0.25 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Baseline (n=19, 16, 17, 17) | 0.26 units on a scale | Standard Deviation 0.452 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Change at Month 12 (n=16, 14, 15, 16) | 0.13 units on a scale | Standard Deviation 0.342 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Baseline (n=19, 16, 17, 17) | 1.05 units on a scale | Standard Deviation 1.508 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Change at Month 12 (n=16, 14, 15, 16) | 0.13 units on a scale | Standard Deviation 0.5 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Baseline (n=19, 16, 17, 17) | 0.25 units on a scale | Standard Deviation 0.577 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Change at Month 12(n=16, 14, 15, 16) | -1.07 units on a scale | Standard Deviation 3.149 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Baseline (n=19, 16, 17, 17) | 0.38 units on a scale | Standard Deviation 0.719 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Change at Month12 (n=16, 14, 15, 16) | 0.07 units on a scale | Standard Deviation 0.267 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Baseline (n=19, 16, 17, 17) | 0.00 units on a scale | Standard Deviation 0 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Baseline (n=19, 16, 17, 17) | 1.75 units on a scale | Standard Deviation 2.933 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Baseline (n=19, 16, 17, 17) | 0.88 units on a scale | Standard Deviation 1.219 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Baseline (n=19, 16, 17, 17) | 0.88 units on a scale | Standard Deviation 1.799 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Change at Month12 (n=16, 14, 15, 16) | 0.47 units on a scale | Standard Deviation 0.99 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Baseline (n=19, 16, 17, 17) | 0.47 units on a scale | Standard Deviation 0.8 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Baseline (n=19, 16, 17, 17) | 1.24 units on a scale | Standard Deviation 1.348 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Change at Month 12(n=16, 14, 15, 16) | -0.27 units on a scale | Standard Deviation 1.033 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Baseline (n=19, 16, 17, 17) | 0.24 units on a scale | Standard Deviation 0.664 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | Osteophyte: Change at Month12 (n=16, 14, 15, 16) | 0.06 units on a scale | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Change at Month 12(n=16, 14, 15, 16) | -0.88 units on a scale | Standard Deviation 1.455 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | BML: Baseline (n=19, 16, 17, 17) | 1.94 units on a scale | Standard Deviation 2.512 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Baseline (n=19, 16, 17, 17) | 0.24 units on a scale | Standard Deviation 0.562 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0.365 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MTS: Baseline (n=19, 16, 17, 17) | 0.53 units on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12 | MES: Change at Month 12 (n=16, 14, 15, 16) | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12
The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.
Time frame: Baseline, Months 3, 6 and 12
Population: The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | 0.028 millimeter | Standard Deviation 0.1441 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -0.058 millimeter | Standard Deviation 0.2648 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 1.598 millimeter | Standard Deviation 0.555 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | 0.041 millimeter | Standard Deviation 0.1873 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 1.903 millimeter | Standard Deviation 0.5685 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -0.101 millimeter | Standard Deviation 0.2318 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -0.029 millimeter | Standard Deviation 0.1847 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -0.066 millimeter | Standard Deviation 0.2887 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 1.758 millimeter | Standard Deviation 0.4901 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -0.176 millimeter | Standard Deviation 0.3274 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -0.131 millimeter | Standard Deviation 0.2441 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -0.046 millimeter | Standard Deviation 0.2544 |
| Placebo | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -0.179 millimeter | Standard Deviation 0.1661 |
| Placebo | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -0.005 millimeter | Standard Deviation 0.1633 |
| Placebo | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -0.043 millimeter | Standard Deviation 0.2088 |
| Placebo | Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 1.641 millimeter | Standard Deviation 0.5625 |
Secondary
Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12
The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.
Time frame: Baseline, Months 3, 6 and 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 130.689 microliter | Standard Deviation 83.7032 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | 1.682 microliter | Standard Deviation 30.2235 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -0.540 microliter | Standard Deviation 34.6432 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -13.492 microliter | Standard Deviation 40.8876 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -5.588 microliter | Standard Deviation 21.5146 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -29.830 microliter | Standard Deviation 47.7638 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -35.800 microliter | Standard Deviation 37.057 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 190.354 microliter | Standard Deviation 130.5796 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -23.469 microliter | Standard Deviation 59.1138 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -9.630 microliter | Standard Deviation 40.2382 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -39.658 microliter | Standard Deviation 80.5121 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 158.125 microliter | Standard Deviation 131.2277 |
| Placebo | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 12 (n=16, 14, 15, 16) | -25.188 microliter | Standard Deviation 36.1098 |
| Placebo | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 3 (n=18, 16, 17, 17) | -7.439 microliter | Standard Deviation 13.7056 |
| Placebo | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Baseline (n=19, 16, 17, 17) | 128.982 microliter | Standard Deviation 116.9241 |
| Placebo | Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12 | Change at Month 6 (n=17, 15, 17, 16) | -14.511 microliter | Standard Deviation 28.3908 |
Secondary
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12
The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.
Time frame: Baseline, Months 3, 6 and 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 12 (n=16, 14, 16, 15) | 24.38 units on a scale | Standard Deviation 28.336 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 12(n=17, 14, 16,16) | 12.61 units on a scale | Standard Deviation 20.208 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Baseline (n=19, 16, 17, 17) | 52.753 units on a scale | Standard Deviation 18.8009 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 6 (n=18,16,17,17) | 19.44 units on a scale | Standard Deviation 21.81 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 3 (n=19, 16, 17, 17) | 16.23 units on a scale | Standard Deviation 19.162 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 6 (n=18, 16, 17, 17) | 18.14 units on a scale | Standard Deviation 18.69 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 3 (n=19, 16, 16, 17) | 16.999 units on a scale | Standard Deviation 16.6813 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 6(n=18, 16, 17, 17) | 17.26 units on a scale | Standard Deviation 18.385 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 6 (n=17, 16, 17, 16) | 27.94 units on a scale | Standard Deviation 26.224 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 3 (n=19, 16, 17, 17) | 9.54 units on a scale | Standard Deviation 24.149 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 6 (n=18, 16, 17, 16) | 21.711 units on a scale | Standard Deviation 19.4701 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Baseline (n=18, 16, 17, 16) | 38.06 units on a scale | Standard Deviation 24.92 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 6 (n=18, 16, 17, 17) | 13.89 units on a scale | Standard Deviation 26.129 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 3 (n=19, 16, 17, 17) | 16.95 units on a scale | Standard Deviation 18.63 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 12 (n=17, 14, 16, 16) | 20.284 units on a scale | Standard Deviation 21.2408 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Baseline (n=19, 16, 17, 17) | 65.20 units on a scale | Standard Deviation 19.074 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Baseline (n=19, 16, 17, 17) | 41.45 units on a scale | Standard Deviation 25.277 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 3 (n=18, 16, 17, 16) | 22.78 units on a scale | Standard Deviation 27.074 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Baseline (n=19, 16, 17, 17) | 68.80 units on a scale | Standard Deviation 16.955 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 12 (n=17, 14, 16, 16) | 16.70 units on a scale | Standard Deviation 20.37 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 12 (n=17, 14, 16, 16) | 12.13 units on a scale | Standard Deviation 27.729 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Baseline (n=19, 16, 17, 17) | 69.89 units on a scale | Standard Deviation 18.053 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms:Change at Month 3(n=19, 16, 17, 17) | 14.10 units on a scale | Standard Deviation 16.94 |
| Sprifermin (AS902330) 10 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 12 (n=17, 14, 16, 16) | 16.99 units on a scale | Standard Deviation 21.603 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms:Change at Month 3(n=19, 16, 17, 17) | 12.95 units on a scale | Standard Deviation 20.982 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 12 (n=17, 14, 16, 16) | 18.06 units on a scale | Standard Deviation 19.543 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 6(n=18, 16, 17, 17) | 17.19 units on a scale | Standard Deviation 16.864 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 12(n=17, 14, 16,16) | 17.86 units on a scale | Standard Deviation 17.994 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 6 (n=18,16,17,17) | 22.40 units on a scale | Standard Deviation 19.496 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Baseline (n=19, 16, 17, 17) | 67.01 units on a scale | Standard Deviation 23.282 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 3 (n=19, 16, 17, 17) | 17.19 units on a scale | Standard Deviation 18.042 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 3 (n=19, 16, 17, 17) | 18.75 units on a scale | Standard Deviation 18.799 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 3 (n=18, 16, 17, 16) | 25.94 units on a scale | Standard Deviation 22.746 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 12 (n=17, 14, 16, 16) | 14.92 units on a scale | Standard Deviation 19.199 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 6 (n=18, 16, 17, 17) | 23.44 units on a scale | Standard Deviation 20.091 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 12 (n=17, 14, 16, 16) | 16.52 units on a scale | Standard Deviation 23.206 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 6 (n=18, 16, 17, 17) | 17.56 units on a scale | Standard Deviation 16.883 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Baseline (n=19, 16, 17, 17) | 50.431 units on a scale | Standard Deviation 12.1996 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 12 (n=16, 14, 16, 15) | 32.05 units on a scale | Standard Deviation 30.07 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 3 (n=19, 16, 16, 17) | 23.563 units on a scale | Standard Deviation 13.5872 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 3 (n=19, 16, 17, 17) | 14.25 units on a scale | Standard Deviation 15.809 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 6 (n=18, 16, 17, 16) | 28.664 units on a scale | Standard Deviation 15.24 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Baseline (n=18, 16, 17, 16) | 46.25 units on a scale | Standard Deviation 23.488 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 12 (n=17, 14, 16, 16) | 25.944 units on a scale | Standard Deviation 17.6274 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Baseline (n=19, 16, 17, 17) | 74.17 units on a scale | Standard Deviation 19.969 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Baseline (n=19, 16, 17, 17) | 67.63 units on a scale | Standard Deviation 20.432 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Baseline (n=19, 16, 17, 17) | 41.41 units on a scale | Standard Deviation 14.591 |
| Sprifermin (AS902330) 30 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 6 (n=17, 16, 17, 16) | 32.19 units on a scale | Standard Deviation 23.307 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Baseline (n=19, 16, 17, 17) | 56.70 units on a scale | Standard Deviation 20.672 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 6 (n=17, 16, 17, 16) | 31.47 units on a scale | Standard Deviation 23.767 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 12 (n=16, 14, 16, 15) | 40.94 units on a scale | Standard Deviation 21.926 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Baseline (n=19, 16, 17, 17) | 34.19 units on a scale | Standard Deviation 15.643 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 3 (n=19, 16, 17, 17) | 16.54 units on a scale | Standard Deviation 23.064 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 6 (n=18, 16, 17, 17) | 23.53 units on a scale | Standard Deviation 17.888 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 12 (n=17, 14, 16, 16) | 29.69 units on a scale | Standard Deviation 17.002 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Baseline (n=19, 16, 17, 17) | 46.045 units on a scale | Standard Deviation 15.2838 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 3 (n=19, 16, 16, 17) | 25.790 units on a scale | Standard Deviation 19.6412 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 6 (n=18, 16, 17, 16) | 30.494 units on a scale | Standard Deviation 18.9965 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 12 (n=17, 14, 16, 16) | 31.787 units on a scale | Standard Deviation 19.1616 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Baseline (n=19, 16, 17, 17) | 59.66 units on a scale | Standard Deviation 17.024 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms:Change at Month 3(n=19, 16, 17, 17) | 21.01 units on a scale | Standard Deviation 13.236 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 6(n=18, 16, 17, 17) | 26.47 units on a scale | Standard Deviation 11.012 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 12(n=17, 14, 16,16) | 29.91 units on a scale | Standard Deviation 14.219 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 3 (n=18, 16, 17, 16) | 27.06 units on a scale | Standard Deviation 25.924 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 3 (n=19, 16, 17, 17) | 24.02 units on a scale | Standard Deviation 20.197 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 6 (n=18,16,17,17) | 26.63 units on a scale | Standard Deviation 16.169 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 12 (n=17, 14, 16, 16) | 31.60 units on a scale | Standard Deviation 14.868 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Baseline (n=19, 16, 17, 17) | 64.01 units on a scale | Standard Deviation 20.694 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 3 (n=19, 16, 17, 17) | 21.80 units on a scale | Standard Deviation 19.302 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 6 (n=18, 16, 17, 17) | 25.09 units on a scale | Standard Deviation 15.637 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 12 (n=17, 14, 16, 16) | 28.22 units on a scale | Standard Deviation 16.183 |
| Sprifermin (AS902330) 100 mcg | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Baseline (n=18, 16, 17, 16) | 38.82 units on a scale | Standard Deviation 18.416 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Baseline (n=19, 16, 17, 17) | 40.07 units on a scale | Standard Deviation 19.398 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 12 (n=17, 14, 16, 16) | 28.47 units on a scale | Standard Deviation 24.163 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Baseline (n=19, 16, 17, 17) | 67.65 units on a scale | Standard Deviation 21.297 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 12 (n=17, 14, 16, 16) | 32.184 units on a scale | Standard Deviation 23.3421 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 12 (n=16, 14, 16, 15) | 50.33 units on a scale | Standard Deviation 29.669 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Baseline (n=19, 16, 17, 17) | 73.83 units on a scale | Standard Deviation 24.326 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 6 (n=18, 16, 17, 16) | 27.658 units on a scale | Standard Deviation 22.8095 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Change at Month 3 (n=19, 16, 16, 17) | 25.152 units on a scale | Standard Deviation 20.1268 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 3 (n=18, 16, 17, 16) | 38.44 units on a scale | Standard Deviation 28.619 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 3 (n=19, 16, 17, 17) | 20.80 units on a scale | Standard Deviation 25.123 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | IKDC Score: Baseline (n=19, 16, 17, 17) | 55.646 units on a scale | Standard Deviation 19.0396 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 12 (n=17, 14, 16, 16) | 41.41 units on a scale | Standard Deviation 28.401 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Baseline (n=18, 16, 17, 16) | 39.38 units on a scale | Standard Deviation 25.747 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 6 (n=18, 16, 17, 17) | 23.05 units on a scale | Standard Deviation 25.792 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 6 (n=18, 16, 17, 17) | 27.94 units on a scale | Standard Deviation 28.821 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS QoL: Change at Month 3 (n=19, 16, 17, 17) | 23.16 units on a scale | Standard Deviation 25.842 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FSRA: Change at Month 6 (n=17, 16, 17, 16) | 42.81 units on a scale | Standard Deviation 29.55 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 3 (n=19, 16, 17, 17) | 24.02 units on a scale | Standard Deviation 25.852 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Baseline (n=19, 16, 17, 17) | 65.20 units on a scale | Standard Deviation 22.569 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 12(n=17, 14, 16,16) | 26.12 units on a scale | Standard Deviation 23.464 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS FDL: Change at Month 12 (n=17, 14, 16, 16) | 24.75 units on a scale | Standard Deviation 25.689 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Pain: Change at Month 6 (n=18,16,17,17) | 27.29 units on a scale | Standard Deviation 25.839 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms: Change at Month 6(n=18, 16, 17, 17) | 22.27 units on a scale | Standard Deviation 23.975 |
| Placebo | Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12 | KOOS Symptoms:Change at Month 3(n=19, 16, 17, 17) | 17.02 units on a scale | Standard Deviation 23.095 |
Secondary
Number of Participants With Acute Inflammatory Reactions
Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.
Time frame: Baseline up to Month 12
Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Acute Inflammatory Reactions | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Acute Inflammatory Reactions | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Acute Inflammatory Reactions | 7 participants |
| Placebo | Number of Participants With Acute Inflammatory Reactions | 2 participants |
Secondary
Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18)
Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.
Time frame: Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12
Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 1 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 2 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Week 4 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 3 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 12 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 1 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 2 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 3 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 12 | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Week 4 | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 1 | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 3 | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Week 4 | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 3 | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 2 | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Week 4 | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 12 | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 2 | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 1 | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 12 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 2 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 3 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 12 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 1 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 12 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Week 4 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Week 4 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 1 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 2 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 3 | 0 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 12 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 12 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 2 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Pre-dose Week 1 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Month 3 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Month 3 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 2 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Pre-dose Week 1 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | BAbs: Week 4 | 1 participants |
| Placebo | Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18) | NAbs: Week 4 | 1 participants |
Secondary
Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12
The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.
Time frame: Baseline, Months 6 and 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -3 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 2 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 0 (n=17, 15, 17, 16) | 13 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 1 (n=16, 14, 15, 16) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 1 (n=17, 15, 17, 16) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 0 (n=16, 14, 15, 16) | 12 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -2 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -3 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -1 (n=16, 14, 15, 16) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -2 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -1 (n=17, 15, 17, 16) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 2 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -1 (n=16, 14, 15, 16) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -3 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -2 (n=17, 15, 17, 16) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -1 (n=17, 15, 17, 16) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 0 (n=17, 15, 17, 16) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 1 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 2 (n=17, 15, 17, 16) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -3 (n=16, 14, 15, 16) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -2 (n=16, 14, 15, 16) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 0 (n=16, 14, 15, 16) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 1 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 2 (n=16, 14, 15, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -3 (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -1 (n=17, 15, 17, 16) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -3 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 1 (n=16, 14, 15, 16) | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -2 (n=16, 14, 15, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -2 (n=17, 15, 17, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 2 (n=16, 14, 15, 16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -1 (n=16, 14, 15, 16) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 0 (n=16, 14, 15, 16) | 9 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 0 (n=17, 15, 17, 16) | 11 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 1 (n=17, 15, 17, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 2 (n=17, 15, 17, 16) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 0 (n=16, 14, 15, 16) | 11 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 2 (n=17, 15, 17, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -1 (n=16, 14, 15, 16) | 4 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 2 (n=16, 14, 15, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -3 (n=17, 15, 17, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -3 (n=16, 14, 15, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -2 (n=17, 15, 17, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of 1 (n=16, 14, 15, 16) | 1 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of -1 (n=17, 15, 17, 16) | 5 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 12: Change value of -2 (n=16, 14, 15, 16) | 0 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 0 (n=17, 15, 17, 16) | 10 participants |
| Placebo | Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12 | Month 6: Change value of 1 (n=17, 15, 17, 16) | 1 participants |
Secondary
Number of Participants With Global Evaluation of Treatment Benefit
Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.
Time frame: Months 3, 6 and 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 6 (n= 18, 16, 17, 17) | 5 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 6 (n= 18, 16, 17, 17) | 7 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 3 (n= 19, 16, 17, 17) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 3 (n= 19, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 6 (n= 18, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 6 (n= 18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 12 (n= 17, 14, 16, 16) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 3 (n= 19, 16, 17, 17) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 12 (n= 17, 14, 16, 16) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 3 (n= 19, 16, 17, 17) | 9 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 12 (n= 17, 14, 16, 16) | 7 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 6 (n= 18, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 3 (n= 19, 16, 17, 17) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 12 (n= 17, 14, 16, 16) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 3 (n= 19, 16, 17, 17) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 3 (n= 19, 16, 17, 17) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 3 (n= 19, 16, 17, 17) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 3 (n= 19, 16, 17, 17) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 3 (n= 19, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 6 (n= 18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 6 (n= 18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 6 (n= 18, 16, 17, 17) | 9 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 6 (n= 18, 16, 17, 17) | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 6 (n= 18, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 12 (n= 17, 14, 16, 16) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 12 (n= 17, 14, 16, 16) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 12 (n= 17, 14, 16, 16) | 6 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 12 (n= 17, 14, 16, 16) | 6 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 3 (n= 19, 16, 17, 17) | 10 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 12 (n= 17, 14, 16, 16) | 7 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 6 (n= 18, 16, 17, 17) | 9 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 6 (n= 18, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 3 (n= 19, 16, 17, 17) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 6 (n= 18, 16, 17, 17) | 5 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 3 (n= 19, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 12 (n= 17, 14, 16, 16) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 6 (n= 18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 3 (n= 19, 16, 17, 17) | 4 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 3 (n= 19, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 6 (n= 18, 16, 17, 17) | 0 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 6 (n= 18, 16, 17, 17) | 2 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 6 (n= 18, 16, 17, 17) | 6 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 6 (n= 18, 16, 17, 17) | 1 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 3 (n= 19, 16, 17, 17) | 1 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 6 (n= 18, 16, 17, 17) | 2 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 3 (n= 19, 16, 17, 17) | 4 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 12 (n= 17, 14, 16, 16) | 6 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 12 (n= 17, 14, 16, 16) | 4 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 6 (n= 18, 16, 17, 17) | 6 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Very Good: Month 3 (n= 19, 16, 17, 17) | 2 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Excellent: Month 3 (n= 19, 16, 17, 17) | 7 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Good: Month 12 (n= 17, 14, 16, 16) | 6 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Poor: Month 12 (n= 17, 14, 16, 16) | 0 participants |
| Placebo | Number of Participants With Global Evaluation of Treatment Benefit | Fair: Month 3 (n= 19, 16, 17, 17) | 3 participants |
Secondary
Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales
MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair \[DDR\] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone \[IBZ\] score 0 (\> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue \[SRT\] score 0 (\>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue \[StRT\] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity \[T2\] Mapping Sequence \[T2MS\] and Hi-Res Sagittal Pharmacodynamic Sequence \[Hi-Res SPS\] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.
Time frame: Months 3 (M3), 6 (M6) and 12 (M12)
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Not Intact (n=16,15,17,16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Isointense (n=5, 4, 3, 6) | 5 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Moderately hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Intact (n=16, 15, 17, 16) | 16 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Markedly hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Hypertrophy (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Isointense (n=4, 5, 3, 6) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Not Intact (n=17,16,17,17) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Moderately hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete<50% (n=4, 4, 3, 6) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Markedly hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-No (n=16, 14, 15, 16) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Intact (n=17, 16, 17, 17) | 17 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Isointense (n=4, 8, 2, 5) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete >50% (n=4, 8, 2, 5) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Moderately hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Markedly hypointense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Markedly hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res SPS, Isointense (n=5, 4, 3, 6) | 5 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Moderately hypointense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Moderately hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete<50% (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Markedly hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res SPS, Isointense (n=4, 8, 2, 5) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res SPS, Isointense (n=4, 5, 3, 6) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Hypertrophy (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Moderately hypointense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-Yes (n=17, 15, 17, 16) | 13 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Markedly hypointense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, subchondral bone exposed (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-No (n=18, 16, 17, 17) | 5 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Complete (n=1, 1, 0, 2) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, subchondral bone exposed (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-No (n=17, 15, 17, 16) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Incomplete (split-like) (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible<50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-Yes (n=3, 3, 1, 3) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible>50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Complete (n=1, 2, 0, 2) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Complete (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-No (n=3, 3, 1, 3) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Incomplete (split-like) (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible<50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-Yes (n=2, 3, 1, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible>50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-Yes (n=2, 5, 1, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Complete (n=1, 2, 0, 1) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Hypertrophy (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-No (n=2, 3, 1, 2) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Incomplete (split-like) (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible<50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-Yes (n=18, 16, 17, 17) | 13 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Not Intact (n=16, 14, 15, 16 | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible>50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface intact (n=1, 1, 0, 2) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete >50% (n=3, 5, 3, 6) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Intact (n=16, 14, 15, 16) | 12 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged < 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged > 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete >50% (n=4, 4, 3, 6) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Not Intact (n=17, 15, 17, 16) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface intact (n=1, 2, 0, 2) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-No (n=2, 5, 1, 2) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged <50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Complete (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Intact (n=17, 15, 17, 16) | 14 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged > 50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete<50% (n=3, 5, 3, 6) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface intact (n=1, 2, 0, 1) | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Not Intact (n=18, 16, 17, 17) | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged <50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged > 50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Intact (n=18, 16, 17, 17) | 16 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Homogeneous (n=4, 3, 0, 4) | 4 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, subchondral bone exposed (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Inhomogenous (n=4, 3, 0, 4) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,Subchondral Lamina Not Intact (n=15,14,15,16) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Homogeneous (n=3, 4, 0, 3) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Inhomogenous (n=3, 4, 0, 3) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-Yes (n=16, 14, 15, 16) | 13 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral Lamina Intact (n=15, 14, 15, 16) | 15 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Homogeneous (n=3, 4, 0, 2) | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Complete (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Inhomogenous(n=3, 4, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Markedly hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible<50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Isointense (n=5, 4, 3, 6) | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-No (n=18, 16, 17, 17) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Intact (n=16, 15, 17, 16) | 15 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Complete (n=4, 4, 3, 6) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Moderately hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-No (n=16, 14, 15, 16) | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Inhomogenous (n=4, 3, 0, 4) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, subchondral bone exposed (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible>50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Not Intact (n=17,16,17,17) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged > 50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Isointense (n=4, 5, 3, 6) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Hypertrophy (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-No (n=2, 3, 1, 2) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Inhomogenous(n=3, 4, 0, 2) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Moderately hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Complete (n=1, 2, 0, 1) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Intact (n=17, 16, 17, 17) | 16 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Not Intact (n=18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Markedly hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Homogeneous (n=3, 4, 0, 2) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface intact (n=1, 2, 0, 1) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Incomplete (split-like) (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Isointense (n=4, 8, 2, 5) | 8 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Hypertrophy (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Markedly hypointense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Not Intact (n=16, 14, 15, 16 | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Moderately hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete >50% (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete<50% (n=3, 5, 3, 6) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible<50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Markedly hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete<50% (n=4, 4, 3, 6) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Moderately hypointense (n=4, 8, 2, 5) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Homogeneous (n=3, 4, 0, 3) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res SPS, Isointense (n=5, 4, 3, 6) | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-Yes (n=17, 15, 17, 16) | 13 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-Yes (n=18, 16, 17, 17) | 14 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged <50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Moderately hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible>50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res SPS, Isointense (n=4, 8, 2, 5) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-No (n=2, 5, 1, 2) | 5 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Markedly hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete<50% (n=4, 8, 2, 5) | 6 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Intact (n=16, 14, 15, 16) | 13 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete >50% (n=4, 4, 3, 6) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res SPS, Isointense (n=4, 5, 3, 6) | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface intact (n=1, 1, 0, 2) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Markedly hypointense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Intact (n=18, 16, 17, 17) | 16 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Moderately hypointense (n=4, 5, 3, 6) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral Lamina Intact (n=15, 14, 15, 16) | 14 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged > 50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged < 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, subchondral bone exposed (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete >50% (n=3, 5, 3, 6) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-No (n=17, 15, 17, 16) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Not Intact (n=17, 15, 17, 16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Complete (n=1, 1, 0, 2) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-Yes (n=16, 14, 15, 16) | 10 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged > 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Complete (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Incomplete (split-like) (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, subchondral bone exposed (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-Yes (n=3, 3, 1, 3) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Inhomogenous (n=3, 4, 0, 3) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible<50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Hypertrophy (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Homogeneous (n=4, 3, 0, 4) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface intact (n=1, 2, 0, 2) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible>50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-Yes (n=2, 5, 1, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-No (n=3, 3, 1, 3) | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Not Intact (n=16,15,17,16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Complete (n=1, 2, 0, 2) | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Intact (n=17, 15, 17, 16) | 15 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,Subchondral Lamina Not Intact (n=15,14,15,16) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged <50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Incomplete (split-like) (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Complete (n=3, 5, 3, 6) | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-Yes (n=2, 3, 1, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged <50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Complete (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Hypertrophy (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete >50% (n=4, 4, 3, 6) | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete<50% (n=4, 4, 3, 6) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, subchondral bone exposed (n=4, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Complete (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Hypertrophy (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete >50% (n=3, 5, 3, 6) | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete<50% (n=3, 5, 3, 6) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, subchondral bone exposed (n=3, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Complete (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Hypertrophy (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete >50% (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete<50% (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, subchondral bone exposed (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Complete (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Incomplete (split-like) (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible<50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible>50% repair tissue(n=1,1,0,2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Complete (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Incomplete (split-like) (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible<50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible>50% repair tissue(n=1,2,0,2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Complete (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Incomplete (split-like) (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible<50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible>50% repair tissue(n=1,2,0,1 | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface intact (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged < 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged > 50% (n=1, 1, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface intact (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged > 50% (n=1, 2, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface intact (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged <50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged > 50% (n=1, 2, 0, 1) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Homogeneous (n=4, 3, 0, 4) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Inhomogenous (n=4, 3, 0, 4) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Homogeneous (n=3, 4, 0, 3) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Inhomogenous (n=3, 4, 0, 3) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Homogeneous (n=3, 4, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Inhomogenous(n=3, 4, 0, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Isointense (n=5, 4, 3, 6) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Moderately hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Markedly hyperintense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Isointense (n=4, 5, 3, 6) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Moderately hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Markedly hyperintense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Isointense (n=4, 8, 2, 5) | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Moderately hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Markedly hyperintense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res SPS, Isointense (n=5, 4, 3, 6) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Moderately hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Markedly hypointense (n=5, 4, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res SPS, Isointense (n=4, 5, 3, 6) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Moderately hypointense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Markedly hypointense (n=4, 5, 3, 6) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res SPS, Isointense (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Moderately hypointense (n=4, 8, 2, 5) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Markedly hypointense (n=4, 8, 2, 5) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Intact (n=17, 16, 17, 17) | 17 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Not Intact (n=17,16,17,17) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Intact (n=16, 15, 17, 16) | 17 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Not Intact (n=16,15,17,16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral Lamina Intact (n=15, 14, 15, 16) | 15 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,Subchondral Lamina Not Intact (n=15,14,15,16) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Intact (n=18, 16, 17, 17) | 17 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Not Intact (n=18, 16, 17, 17) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Intact (n=17, 15, 17, 16) | 16 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Not Intact (n=17, 15, 17, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Intact (n=16, 14, 15, 16) | 14 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Not Intact (n=16, 14, 15, 16 | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-No (n=2, 3, 1, 2) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-Yes (n=2, 3, 1, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-No (n=3, 3, 1, 3) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-No (n=17, 15, 17, 16) | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-Yes (n=17, 15, 17, 16) | 14 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-No (n=16, 14, 15, 16) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-Yes (n=16, 14, 15, 16) | 14 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-Yes (n=3, 3, 1, 3) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-No (n=2, 5, 1, 2) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-Yes (n=2, 5, 1, 2) | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-No (n=18, 16, 17, 17) | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-Yes (n=18, 16, 17, 17) | 16 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Inhomogenous(n=3, 4, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, StRT, Homogeneous (n=3, 4, 0, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete<50% (n=3, 5, 3, 6) | 6 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Not Intact (n=16,15,17,16) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Inhomogenous (n=3, 4, 0, 3) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, StRT, Homogeneous (n=3, 4, 0, 3) | 3 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-Yes (n=18, 16, 17, 17) | 14 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral Lamina Intact (n=15, 14, 15, 16) | 16 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Inhomogenous (n=4, 3, 0, 4) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, StRT, Homogeneous (n=4, 3, 0, 4) | 4 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-Yes (n=16, 14, 15, 16) | 13 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,Subchondral Lamina Not Intact (n=15,14,15,16) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged > 50% (n=1, 2, 0, 1) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface damaged <50% (n=1, 2, 0, 1) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Effusion-No (n=18, 16, 17, 17) | 3 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Intact (n=18, 16, 17, 17) | 17 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, SRT, surface intact (n=1, 2, 0, 1) | 1 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged > 50% (n=1, 2, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-Yes (n=3, 3, 1, 3) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral bone Not Intact (n=18, 16, 17, 17) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface damaged <50% (n=1, 2, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, SRT, surface intact (n=1, 2, 0, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, incomplete >50% (n=3, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Intact (n=17, 15, 17, 16) | 15 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged > 50% (n=1, 1, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface damaged < 50% (n=1, 1, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Hypertrophy (n=3, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral bone Not Intact (n=17, 15, 17, 16) | 1 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, SRT, surface intact (n=1, 1, 0, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible>50% repair tissue(n=1,2,0,1 | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Hypertrophy (n=4, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Intact (n=16, 14, 15, 16) | 16 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12,IBZ,Defect visible<50% repair tissue(n=1,2,0,1 | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Incomplete (split-like) (n=1, 2, 0, 1) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-No (n=2, 5, 1, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Subchondral bone Not Intact (n=16, 14, 15, 16 | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, IBZ, Complete (n=1, 2, 0, 1) | 1 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible>50% repair tissue(n=1,2,0,2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, Complete (n=3, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-No (n=2, 3, 1, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6,IBZ,Defect visible<50% repair tissue(n=1,2,0,2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Incomplete (split-like) (n=1, 2, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, subchondral bone exposed (n=4, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Adhesions-Yes (n=2, 3, 1, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, IBZ, Complete (n=1, 2, 0, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible>50% repair tissue(n=1,1,0,2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, Complete (n=4, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Adhesions-No (n=3, 3, 1, 3) | 3 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3,IBZ,Defect visible<50% repair tissue(n=1,1,0,2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Incomplete (split-like) (n=1, 1, 0, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, IBZ, Complete (n=1, 1, 0, 2) | 2 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, subchondral bone exposed (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Adhesions-Yes (n=2, 5, 1, 2) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-No (n=17, 15, 17, 16) | 4 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete<50% (n=4, 8, 2, 5) | 5 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, incomplete >50% (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Moderately hypointense (n=4, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res SPS, Isointense (n=4, 5, 3, 6) | 6 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete<50% (n=4, 4, 3, 6) | 5 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Hi-Res, Markedly hypointense (n=4, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Markedly hypointense (n=5, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res, Moderately hypointense (n=5, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Effusion-Yes (n=17, 15, 17, 16) | 12 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res SPS, Isointense (n=4, 8, 2, 5) | 5 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Hi-Res SPS, Isointense (n=5, 4, 3, 6) | 6 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Markedly hyperintense (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Hypertrophy (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Moderately hypointense (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Moderately hyperintense (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, T2MS, Isointense (n=4, 8, 2, 5) | 5 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, DDR, Complete (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Hi-Res, Markedly hypointense (n=4, 8, 2, 5) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Markedly hyperintense (n=4, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Moderately hyperintense (n=4, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, DDR, incomplete >50% (n=4, 4, 3, 6) | 1 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Intact (n=17, 16, 17, 17) | 17 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, T2MS, Isointense (n=4, 5, 3, 6) | 6 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Markedly hyperintense (n=5, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M12, Effusion-No (n=16, 14, 15, 16) | 3 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, Subchondral Lamina Not Intact (n=17,16,17,17) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Moderately hyperintense (n=5, 4, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M3, T2MS, Isointense (n=5, 4, 3, 6) | 6 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, DDR, subchondral bone exposed (n=3, 5, 3, 6) | 0 participants |
| Placebo | Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales | M6, Subchondral Lamina Intact (n=16, 15, 17, 16) | 16 participants |
Secondary
Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12
The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 \[patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral\], synovitis, and effusion) scores at Month 12 were reported.
Time frame: Month 12
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella medial | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella lateral | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur medial trochlea | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur lateral trochlea | 3 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 medial weight bearing femur | 9 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 lateral weight bearing femur | 2 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia medial | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia lateral | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Synovitis | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Effusion | 13 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur medial trochlea | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Synovitis | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur lateral trochlea | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 medial weight bearing femur | 4 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 lateral weight bearing femur | 3 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia medial | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Effusion | 11 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia lateral | 2 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella medial | 1 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella lateral | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia lateral | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia medial | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Effusion | 13 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella medial | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur lateral trochlea | 1 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 lateral weight bearing femur | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Synovitis | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella lateral | 3 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 medial weight bearing femur | 2 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur medial trochlea | 1 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 medial weight bearing femur | 3 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia lateral | 0 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 lateral weight bearing femur | 2 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Effusion | 8 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 tibia medial | 1 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella lateral | 3 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur medial trochlea | 1 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 femur lateral trochlea | 1 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Cartilage 1 patella medial | 3 participants |
| Placebo | Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12 | Synovitis | 0 participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.
Time frame: Baseline up to Month 12
Population: Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs Leading to Discontinuation | 0 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Local TEAEs | 9 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Systemic TEAEs | 6 participants |
| Sprifermin (AS902330) 10 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs | 10 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Systemic TEAEs | 7 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs Leading to Discontinuation | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Local TEAEs | 8 participants |
| Sprifermin (AS902330) 30 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs | 11 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Systemic TEAEs | 5 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs | 12 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Local TEAEs | 11 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs Leading to Discontinuation | 0 participants |
| Sprifermin (AS902330) 100 mcg | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs Leading to Discontinuation | 1 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Local TEAEs | 11 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | TEAEs | 14 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | Systemic TEAEs | 7 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Secondary
Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6
Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: (\[volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively\]\*100)/volume or thickness at baseline.
Time frame: Baseline, Months 3 and 6
Population: The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sprifermin (AS902330) 10 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 3 (n=18, 16, 17, 17) | 3.097 Percent change | Standard Deviation 24.7727 |
| Sprifermin (AS902330) 10 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 6 (n=17, 15, 17, 16) | 0.922 Percent change | Standard Deviation 28.8298 |
| Sprifermin (AS902330) 10 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 3 (n=18, 16, 17, 17) | 3.126 Percent change | Standard Deviation 9.7969 |
| Sprifermin (AS902330) 10 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 6 (n=17, 15, 17, 16) | 3.461 Percent change | Standard Deviation 11.7686 |
| Sprifermin (AS902330) 30 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 6 (n=17, 15, 17, 16) | -11.118 Percent change | Standard Deviation 32.3251 |
| Sprifermin (AS902330) 30 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 3 (n=18, 16, 17, 17) | -1.969 Percent change | Standard Deviation 9.2075 |
| Sprifermin (AS902330) 30 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 6 (n=17, 15, 17, 16) | -3.184 Percent change | Standard Deviation 14.1109 |
| Sprifermin (AS902330) 30 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 3 (n=18, 16, 17, 17) | -1.596 Percent change | Standard Deviation 22.6831 |
| Sprifermin (AS902330) 100 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 3 (n=18, 16, 17, 17) | -1.327 Percent change | Standard Deviation 16.4475 |
| Sprifermin (AS902330) 100 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 6 (n=17, 15, 17, 16) | -7.518 Percent change | Standard Deviation 32.6967 |
| Sprifermin (AS902330) 100 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 6 (n=17, 15, 17, 16) | -5.439 Percent change | Standard Deviation 16.1866 |
| Sprifermin (AS902330) 100 mcg | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 3 (n=18, 16, 17, 17) | -2.054 Percent change | Standard Deviation 28.3639 |
| Placebo | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 6 (n=17, 15, 17, 16) | -3.106 Percent change | Standard Deviation 14.1901 |
| Placebo | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 6 (n=17, 15, 17, 16) | -6.792 Percent change | Standard Deviation 27.8652 |
| Placebo | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Volume: Month 3 (n=18, 16, 17, 17) | -3.307 Percent change | Standard Deviation 12.3879 |
| Placebo | Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6 | Thickness: Month 3 (n=18, 16, 17, 17) | -0.810 Percent change | Standard Deviation 10.9976 |