Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis of knee, Recombinant Human Fibroblast Growth Factor-18 (rhFGF-18), Sprifermin, Placebo
Brief summary
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.
Detailed description
Participants were equally randomized to either one of 4 treatment arms or a placebo arm. The trial consists of a Screening period lasting up to 42 days, a two-year double-blind placebo-controlled (DBPC) treatment phase, which begins at randomization (Week 0) and ends at Year 2, and a 3-year extended follow-up phase.
Interventions
DRUGSprifermin
Participants received Sprifermin as intra-articular injection.
DRUGPlacebo
Participants received Placebo matched to sprifermin as intra-articular injection.
Sponsors
Nordic Bioscience A/S
EMD Serono Research & Development Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age from 40 to 85 years; of either sex * Primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray criteria in the target knee at screening * Pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month) * A history of pain due to Osteoarthritis in the target knee for at least 6 months * A protocol-specified pain score for the target knee in response to Question 1 of the WOMAC pain index (how much pain have you had \[in the target knee, over the past 48 hours\] when walking on a flat surface?) after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids, and/or tramadol * Women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial
Exclusion criteria
* Malalignment of greater than 5 degrees in the femorotibial axis of the target knee * Clinical signs of inflammation (redness) in the target knee * Intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before Screening * Planned knee surgery (affecting either the target or the contralateral knee) within the next two years * Concomitant conditions or treatments deemed to be incompatible with trial participation * Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil * Pregnancy or breastfeeding * Participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening * Legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Baseline, Year 2 (Week 104) | The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | The 20-meter walk test is an objective test of physical function which consists of measuring the time needed for the participant to walk 20 meters at a normal pace. A stopwatch was used for time measurement. |
| Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | The Patient Global Assessment is based on participant's answer to the question Considering all the ways your osteoarthritis of the knee has affected you during the last 48 Hours, select the number that best describes the impact of your knee osteoarthritis on your daily life, and can take on values between 0-10 (0=None, 10=Extreme), for summaries the values are rescaled to 0-100 by multiplication with 10. Higher scores indicated worsening of condition. A negative value in change in Patient's Global Assessment is indicative of an improvement. |
| Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Baseline, Week 52 and 104 | Change in joint space narrowing was visualized with the fixed flexion knee radiograph. Determination of joint space narrowing by X-ray is considered to be a semi-quantitative method for assessment of progression of knee Osteoarthritis (OA). X-rays of both the target knee and the contralateral knee were performed. X-rays were read centrally. X-ray images were used to measure mJSW in the medial femorotibial and lateral femorotibial compartments and to determine the participant's baseline Kellgren-Lawrence grades (KLG). |
| Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Baseline, Week 52, Week 78 and Week 104 | WOMAC pain subscale consists of 5 questions (Likert Scale) relating to pain. Sum of items of pain subscale ranges from 0-11. Higher scores=worse pain. Stiffness subscale consists of 2 questions relating articular function. Sum of items of stiffness subscale ranges from 0-8. Higher scores=worse function. Physical function subscale consists of 17 question relating to physical activities. Sum of items of physical function subscale ranges from 0-68. Higher scores= worse functional limitations. Each sub-scale is directly transformed into a 0-100 scale, where higher score indicates worse condition. WOMAC total score(24questions) is sum of total subscales which was directly transformed into score range from 0-100. Higher scores=worse condition. Negative value in change is indicative of improvement. |
| Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Baseline, Week 26, 52, 78 and 104 | The change in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint at Week 26, 52, 78 and 104 was calculated based on qMRI. |
| Synovial Fluid Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | Levels of sprifermin/FGF-18 in synovial fluid were measured to provide a first estimate of the residence time of sprifermin in the synovial fluid. |
| Serum Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | — |
| Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78 | The change in cartilage thickness was calculated based on quantitative magnetic resonance imaging (qMRI). |
Countries
Argentina, Czechia, Denmark, Estonia, Hong Kong, Poland, Romania, United States
Participant flow
Pre-assignment details
A total of 549 participants were randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received Placebo matched to Sprifermin as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months. | 108 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months. | 110 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles Participants received Sprifermin 30 micrograms (mcg) as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months. | 111 |
| Sprifermin (AS902330) 100 mcg/Placebo- 2 Cycles Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 0, 1, 2 in Cycle 1 and at week 52, 53, 54 in Cycle 3; and received placebo matched to Sprifermin once every week for 3 consecutive weeks for 2 alternative cycles, that is at week 26, 27, 28 in Cycle 2 and at week 78, 79, 80 in Cycle 4 at interval of 6 months. | 110 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles Participants received Sprifermin 100 mcg as intra-articular injection once every week for 3 consecutive weeks for 4 cycles, that is at week 0, 1, 2 in Cycle 1; at week 26, 27, 28 in Cycle 2; at week 52, 53, 54 in Cycle 3 and at week 78, 79, 80 in Cycle 4 at interval of 6 months. | 110 |
| Total | 549 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 | 9 | 3 | 2 |
| Overall Study | Death | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Disease progression | 2 | 2 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 0 | 4 |
| Overall Study | Other Un-specified | 13 | 9 | 8 | 7 | 15 |
| Overall Study | Protocol Violation | 6 | 0 | 3 | 2 | 2 |
| Overall Study | Withdrew consent | 13 | 13 | 14 | 14 | 9 |
Baseline characteristics
| Characteristic | Total | Placebo | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Sprifermin (AS902330) 30 mcg- 4 Cycles | Sprifermin (AS902330) 100 mcg/Placebo- 2 Cycles | Sprifermin (AS902330) 100 mcg- 4 Cycles |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 299 Participants | 54 Participants | 64 Participants | 59 Participants | 58 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 250 Participants | 54 Participants | 46 Participants | 52 Participants | 52 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 547 Participants | 107 Participants | 109 Participants | 111 Participants | 110 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 110 Participants | 21 Participants | 22 Participants | 23 Participants | 23 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 439 Participants | 87 Participants | 88 Participants | 88 Participants | 87 Participants | 89 Participants |
| Sex: Female, Male Female | 379 Participants | 76 Participants | 73 Participants | 80 Participants | 77 Participants | 73 Participants |
| Sex: Female, Male Male | 170 Participants | 32 Participants | 37 Participants | 31 Participants | 33 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 107 | 0 / 109 | 0 / 111 | 0 / 111 | 0 / 109 |
| other Total, other adverse events | 105 / 107 | 106 / 109 | 109 / 111 | 106 / 111 | 107 / 109 |
| serious Total, serious adverse events | 39 / 107 | 35 / 109 | 34 / 111 | 32 / 111 | 41 / 109 |
Outcome results
Primary
Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2
The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI).
Time frame: Baseline, Year 2 (Week 104)
Population: Modified intent to treat (ITT) analysis set included all randomized participants that is, only planned treatment regimen was used and who had a baseline, at least 1 post-treatment qMRI assessment available in double-blind placebo-controlled part. Here Number of Participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | -0.02 millimeters | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | -0.01 millimeters | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | 0.00 millimeters | Standard Deviation 0.07 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | 0.02 millimeters | Standard Deviation 0.08 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | 0.03 millimeters | Standard Deviation 0.07 |
Comparison: Descriptive statistics was provided for primary endpoint.95% CI: [-0.01, 0.03]
Comparison: Descriptive statistics was provided for primary endpoint.95% CI: [-0.01, 0.04]
Comparison: Descriptive statistics was provided for primary endpoint.95% CI: [0.02, 0.06]
Comparison: Descriptive statistics was provided for primary endpoint.95% CI: [0.03, 0.07]
Secondary
Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint
The change in cartilage thickness was calculated based on quantitative magnetic resonance imaging (qMRI).
Time frame: Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78
Population: Modified ITT analysis set was used. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 78 | 0.00 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.06 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 26 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 104 | -0.03 millimeter | Standard Deviation 0.12 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 78 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 78 | -0.01 millimeter | Standard Deviation 0.07 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 104 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 26 | -0.01 millimeter | Standard Deviation 0.05 |
| Placebo | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 78 | 0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 78 | -0.01 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 78 | 0.00 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.04 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 104 | -0.02 millimeter | Standard Deviation 0.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 104 | -0.01 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 52 | 0.00 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 26 | -0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 52 | -0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 78 | 0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 104 | -0.01 millimeter | Standard Deviation 0.08 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 78 | 0.01 millimeter | Standard Deviation 0.08 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 104 | 0.00 millimeter | Standard Deviation 0.09 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 26 | 0.00 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 52 | 0.00 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 78 | 0.06 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 104 | 0.00 millimeter | Standard Deviation 0.11 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 26 | 0.01 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 52 | 0.00 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 78 | 0.02 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 52 | 0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 78 | 0.01 millimeter | Standard Deviation 0.1 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 52 | 0.02 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 104 | 0.04 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 26 | 0.01 millimeter | Standard Deviation 0.04 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 26 | 0.02 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 78 | 0.03 millimeter | Standard Deviation 0.07 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 26 | 0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 78 | 0.03 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 104 | 0.02 millimeter | Standard Deviation 0.08 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 104 | 0.04 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 78 | 0.03 millimeter | Standard Deviation 0.08 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 78 | 0.03 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 26 | 0.01 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial: Change at Week 52 | 0.01 millimeter | Standard Deviation 0.06 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Total: Change at Week 52 | 0.01 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 52 | 0.02 millimeter | Standard Deviation 0.05 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Lateral: Change at Week 26 | 0.02 millimeter | Standard Deviation 0.05 |
Secondary
Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104
The change in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint at Week 26, 52, 78 and 104 was calculated based on qMRI.
Time frame: Baseline, Week 26, 52, 78 and 104
Population: Modified ITT analysis set was used. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 78 | -1.8 microliter | Standard Deviation 89.7 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 26 | 0.0 microliter | Standard Deviation 112.2 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 104 | -14.5 microliter | Standard Deviation 87.2 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 52 | -23.7 microliter | Standard Deviation 155.7 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 104 | -41.0 microliter | Standard Deviation 192.1 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 52 | -10.2 microliter | Standard Deviation 100.7 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 52 | -12.7 microliter | Standard Deviation 94 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 78 | -10.3 microliter | Standard Deviation 176.8 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 26 | -13.0 microliter | Standard Deviation 163.2 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 26 | -12.8 microliter | Standard Deviation 84.4 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 78 | -8.9 microliter | Standard Deviation 125.3 |
| Placebo | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 104 | -55.5 microliter | Standard Deviation 239.5 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 78 | -7.0 microliter | Standard Deviation 153.7 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 52 | -17.5 microliter | Standard Deviation 141.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 78 | 13.9 microliter | Standard Deviation 113.6 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 52 | -2.9 microliter | Standard Deviation 127.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 26 | 1.7 microliter | Standard Deviation 110.8 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 78 | 6.9 microliter | Standard Deviation 228.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 104 | -6.8 microliter | Standard Deviation 144.9 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 52 | -20.4 microliter | Standard Deviation 217.6 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 104 | -21.4 microliter | Standard Deviation 198.3 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 104 | -28.2 microliter | Standard Deviation 275.7 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 26 | 2.5 microliter | Standard Deviation 147 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 26 | 0.8 microliter | Standard Deviation 82 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 78 | 44.8 microliter | Standard Deviation 195.3 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 26 | -3.2 microliter | Standard Deviation 99.5 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 52 | -7.0 microliter | Standard Deviation 103.7 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 78 | 23.6 microliter | Standard Deviation 109.3 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 104 | 3.6 microliter | Standard Deviation 123.9 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 26 | 1.5 microliter | Standard Deviation 102.3 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 52 | 2.7 microliter | Standard Deviation 98.2 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 104 | 7.2 microliter | Standard Deviation 134.8 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 26 | -2.9 microliter | Standard Deviation 161.8 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 52 | -5.5 microliter | Standard Deviation 169 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 78 | 21.6 microliter | Standard Deviation 129 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 104 | 9.5 microliter | Standard Deviation 205.7 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 26 | 31.3 microliter | Standard Deviation 87.7 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 104 | 75.5 microliter | Standard Deviation 111.8 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 104 | 19.5 microliter | Standard Deviation 202.3 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 26 | 16.7 microliter | Standard Deviation 89.8 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 26 | 48.4 microliter | Standard Deviation 150.9 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 78 | 33.2 microliter | Standard Deviation 177 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 52 | 36.2 microliter | Standard Deviation 203.1 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 52 | 3.6 microliter | Standard Deviation 127.5 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 104 | 96.6 microliter | Standard Deviation 271.1 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 78 | 89.9 microliter | Standard Deviation 272.6 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 52 | 32.4 microliter | Standard Deviation 107.5 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 78 | 55.9 microliter | Standard Deviation 123.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 78 | 109.1 microliter | Standard Deviation 219.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 26 | 16.5 microliter | Standard Deviation 114.2 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 52 | 44.7 microliter | Standard Deviation 163.2 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 104 | 67.9 microliter | Standard Deviation 112.5 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 104 | 48.6 microliter | Standard Deviation 150.7 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 52 | 16.5 microliter | Standard Deviation 110.6 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 52 | 28.1 microliter | Standard Deviation 87.3 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 78 | 55.2 microliter | Standard Deviation 101.6 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 26 | 41.5 microliter | Standard Deviation 166.6 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Medial: Change at Week 78 | 53.9 microliter | Standard Deviation 147.3 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Lateral: Change at Week 26 | 25.1 microliter | Standard Deviation 85.8 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Total: Change at Week 104 | 116.5 microliter | Standard Deviation 233.5 |
Secondary
Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104
Change in joint space narrowing was visualized with the fixed flexion knee radiograph. Determination of joint space narrowing by X-ray is considered to be a semi-quantitative method for assessment of progression of knee Osteoarthritis (OA). X-rays of both the target knee and the contralateral knee were performed. X-rays were read centrally. X-ray images were used to measure mJSW in the medial femorotibial and lateral femorotibial compartments and to determine the participant's baseline Kellgren-Lawrence grades (KLG).
Time frame: Baseline, Week 52 and 104
Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 52 | -0.10 millimeter | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 104 | -0.11 millimeter | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 52 | 0.07 millimeter | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 104 | -0.07 millimeter | Standard Deviation 0.49 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 52 | -0.05 millimeter | Standard Deviation 0.53 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 104 | -0.03 millimeter | Standard Deviation 0.64 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 104 | -0.09 millimeter | Standard Deviation 0.73 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 52 | -0.03 millimeter | Standard Deviation 0.62 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 104 | 0.01 millimeter | Standard Deviation 0.65 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 104 | 0.03 millimeter | Standard Deviation 0.52 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 52 | 0.16 millimeter | Standard Deviation 0.54 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 52 | -0.04 millimeter | Standard Deviation 0.43 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 52 | 0.02 millimeter | Standard Deviation 0.55 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 104 | -0.05 millimeter | Standard Deviation 0.66 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 104 | 0.19 millimeter | Standard Deviation 0.49 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 52 | 0.10 millimeter | Standard Deviation 0.37 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 104 | 0.19 millimeter | Standard Deviation 0.49 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Lateral: Change at Week 52 | 0.14 millimeter | Standard Deviation 0.43 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 104 | -0.07 millimeter | Standard Deviation 0.86 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Medial: Change at Week 52 | -0.04 millimeter | Standard Deviation 0.57 |
Secondary
Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104
The 20-meter walk test is an objective test of physical function which consists of measuring the time needed for the participant to walk 20 meters at a normal pace. A stopwatch was used for time measurement.
Time frame: Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104
Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -2.1 seconds | Standard Deviation 3.9 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -1.6 seconds | Standard Deviation 4 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -1.3 seconds | Standard Deviation 3.7 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -1.2 seconds | Standard Deviation 2.9 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -1.1 seconds | Standard Deviation 3.6 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -1.7 seconds | Standard Deviation 4.2 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -1.8 seconds | Standard Deviation 3.6 |
| Placebo | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -1.6 seconds | Standard Deviation 3.7 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -0.4 seconds | Standard Deviation 3.9 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -1.1 seconds | Standard Deviation 3.6 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -1.0 seconds | Standard Deviation 3.2 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -1.5 seconds | Standard Deviation 4.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -0.5 seconds | Standard Deviation 3.4 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -1.0 seconds | Standard Deviation 4 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -1.2 seconds | Standard Deviation 4.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -0.4 seconds | Standard Deviation 4 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -0.5 seconds | Standard Deviation 2.6 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -0.8 seconds | Standard Deviation 2.8 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -0.7 seconds | Standard Deviation 2.5 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -0.7 seconds | Standard Deviation 2.5 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -0.3 seconds | Standard Deviation 2.6 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -0.9 seconds | Standard Deviation 2.5 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -1.1 seconds | Standard Deviation 2.7 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -0.8 seconds | Standard Deviation 3.4 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -1.3 seconds | Standard Deviation 2.6 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -1.1 seconds | Standard Deviation 2.8 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -1.8 seconds | Standard Deviation 3.1 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -1.6 seconds | Standard Deviation 3 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -0.8 seconds | Standard Deviation 2.2 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -1.4 seconds | Standard Deviation 2.9 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -0.4 seconds | Standard Deviation 7.9 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -1.0 seconds | Standard Deviation 2.9 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -1.3 seconds | Standard Deviation 3.2 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -1.1 seconds | Standard Deviation 3.3 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -1.3 seconds | Standard Deviation 3 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -1.4 seconds | Standard Deviation 3.2 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -1.3 seconds | Standard Deviation 2.8 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -1.6 seconds | Standard Deviation 3.4 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -1.3 seconds | Standard Deviation 3.2 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -1.7 seconds | Standard Deviation 3.5 |
Secondary
Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104
The Patient Global Assessment is based on participant's answer to the question Considering all the ways your osteoarthritis of the knee has affected you during the last 48 Hours, select the number that best describes the impact of your knee osteoarthritis on your daily life, and can take on values between 0-10 (0=None, 10=Extreme), for summaries the values are rescaled to 0-100 by multiplication with 10. Higher scores indicated worsening of condition. A negative value in change in Patient's Global Assessment is indicative of an improvement.
Time frame: Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104
Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -16.6 score on a scale | Standard Deviation 23.5 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -22.7 score on a scale | Standard Deviation 26.5 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -27.5 score on a scale | Standard Deviation 25 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -18.9 score on a scale | Standard Deviation 26.2 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -16.3 score on a scale | Standard Deviation 22.3 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -19.6 score on a scale | Standard Deviation 25.8 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -22.7 score on a scale | Standard Deviation 24.6 |
| Placebo | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -25.8 score on a scale | Standard Deviation 25.6 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -13.9 score on a scale | Standard Deviation 20.6 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -21.5 score on a scale | Standard Deviation 24.1 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -21.7 score on a scale | Standard Deviation 21.9 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -15.1 score on a scale | Standard Deviation 22.7 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -17.2 score on a scale | Standard Deviation 22.5 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -23.0 score on a scale | Standard Deviation 22.3 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -22.3 score on a scale | Standard Deviation 24.5 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -20.9 score on a scale | Standard Deviation 21.2 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -17.0 score on a scale | Standard Deviation 25 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -19.2 score on a scale | Standard Deviation 24.9 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -21.7 score on a scale | Standard Deviation 24.8 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -17.7 score on a scale | Standard Deviation 25.3 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -18.0 score on a scale | Standard Deviation 23.9 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -22.3 score on a scale | Standard Deviation 23 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -23.1 score on a scale | Standard Deviation 25.7 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -23.8 score on a scale | Standard Deviation 24.9 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -15.0 score on a scale | Standard Deviation 23.2 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -18.7 score on a scale | Standard Deviation 22.4 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -19.5 score on a scale | Standard Deviation 25.2 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -22.1 score on a scale | Standard Deviation 25.6 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -20.5 score on a scale | Standard Deviation 24.3 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -21.1 score on a scale | Standard Deviation 26.3 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -22.0 score on a scale | Standard Deviation 25.4 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -21.6 score on a scale | Standard Deviation 25.8 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 26 | -19.1 score on a scale | Standard Deviation 24.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 78 | -24.2 score on a scale | Standard Deviation 24.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 90 | -26.2 score on a scale | Standard Deviation 24.9 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 52 | -21.6 score on a scale | Standard Deviation 24 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 38 | -18.4 score on a scale | Standard Deviation 25.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 104 | -25.8 score on a scale | Standard Deviation 22.8 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 12 | -16.7 score on a scale | Standard Deviation 22.1 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Change at Week 64 | -21.3 score on a scale | Standard Deviation 24.6 |
Secondary
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104
WOMAC pain subscale consists of 5 questions (Likert Scale) relating to pain. Sum of items of pain subscale ranges from 0-11. Higher scores=worse pain. Stiffness subscale consists of 2 questions relating articular function. Sum of items of stiffness subscale ranges from 0-8. Higher scores=worse function. Physical function subscale consists of 17 question relating to physical activities. Sum of items of physical function subscale ranges from 0-68. Higher scores= worse functional limitations. Each sub-scale is directly transformed into a 0-100 scale, where higher score indicates worse condition. WOMAC total score(24questions) is sum of total subscales which was directly transformed into score range from 0-100. Higher scores=worse condition. Negative value in change is indicative of improvement.
Time frame: Baseline, Week 52, Week 78 and Week 104
Population: Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 52 | -18.88 score on a scale | Standard Deviation 24.72 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 78 | -18.41 score on a scale | Standard Deviation 20.43 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 104 | -25.37 score on a scale | Standard Deviation 20.6 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 104 | -20.89 score on a scale | Standard Deviation 20.1 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 52 | -18.51 score on a scale | Standard Deviation 19.49 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 78 | -17.38 score on a scale | Standard Deviation 21.01 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 52 | -15.51 score on a scale | Standard Deviation 19.14 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 78 | -20.44 score on a scale | Standard Deviation 26.76 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 104 | -22.02 score on a scale | Standard Deviation 19.7 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 78 | -21.04 score on a scale | Standard Deviation 20.81 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 52 | -16.42 score on a scale | Standard Deviation 18.61 |
| Placebo | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 104 | -23.20 score on a scale | Standard Deviation 25.84 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 52 | -17.97 score on a scale | Standard Deviation 16.95 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 78 | -18.23 score on a scale | Standard Deviation 19.41 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 104 | -20.73 score on a scale | Standard Deviation 20.22 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 104 | -20.00 score on a scale | Standard Deviation 20.99 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 78 | -23.00 score on a scale | Standard Deviation 20.42 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 104 | -23.22 score on a scale | Standard Deviation 21.42 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 78 | -19.47 score on a scale | Standard Deviation 25.87 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 52 | -18.52 score on a scale | Standard Deviation 22.89 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 78 | -19.34 score on a scale | Standard Deviation 19.15 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 104 | -20.56 score on a scale | Standard Deviation 23.93 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 52 | -21.55 score on a scale | Standard Deviation 18.36 |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 52 | -16.84 score on a scale | Standard Deviation 17.64 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 104 | -21.42 score on a scale | Standard Deviation 21.37 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 78 | -16.36 score on a scale | Standard Deviation 20.35 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 78 | -18.19 score on a scale | Standard Deviation 21.15 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 52 | -12.01 score on a scale | Standard Deviation 18.04 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 104 | -17.75 score on a scale | Standard Deviation 22.74 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 52 | -15.40 score on a scale | Standard Deviation 18.31 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 52 | -12.64 score on a scale | Standard Deviation 17.42 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 104 | -19.06 score on a scale | Standard Deviation 21.52 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 104 | -19.44 score on a scale | Standard Deviation 20.88 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 78 | -16.00 score on a scale | Standard Deviation 20.82 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 52 | -11.09 score on a scale | Standard Deviation 21.14 |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 78 | -14.94 score on a scale | Standard Deviation 23.66 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 52 | -21.12 score on a scale | Standard Deviation 19.73 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 78 | -23.21 score on a scale | Standard Deviation 19.42 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 104 | -23.15 score on a scale | Standard Deviation 18.18 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 52 | -16.68 score on a scale | Standard Deviation 20.93 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 78 | -19.63 score on a scale | Standard Deviation 20.38 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 104 | -17.76 score on a scale | Standard Deviation 20.75 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 52 | -14.80 score on a scale | Standard Deviation 19.07 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 78 | -17.51 score on a scale | Standard Deviation 18.96 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 104 | -17.03 score on a scale | Standard Deviation 20.16 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 52 | -16.29 score on a scale | Standard Deviation 18.35 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 78 | -18.88 score on a scale | Standard Deviation 18.15 |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 104 | -18.37 score on a scale | Standard Deviation 18.69 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 104 | -22.79 score on a scale | Standard Deviation 24.6 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 52 | -18.29 score on a scale | Standard Deviation 18.25 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 78 | -21.44 score on a scale | Standard Deviation 23.99 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Stiffness: Change at Week 52 | -17.35 score on a scale | Standard Deviation 22.16 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 78 | -23.23 score on a scale | Standard Deviation 18.41 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 104 | -22.08 score on a scale | Standard Deviation 19.11 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Total: Change at Week 78 | -20.29 score on a scale | Standard Deviation 18.49 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 52 | -23.34 score on a scale | Standard Deviation 17.92 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Pain: Change at Week 104 | -26.06 score on a scale | Standard Deviation 18.39 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 104 | -20.82 score on a scale | Standard Deviation 20.39 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 78 | -19.29 score on a scale | Standard Deviation 19.56 |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Function: Change at Week 52 | -16.91 score on a scale | Standard Deviation 19.69 |
Secondary
Serum Levels of Sprifermin/FGF-18
Time frame: Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days)
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Serum Levels of Sprifermin/FGF-18 | NA picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Serum Levels of Sprifermin/FGF-18 | NA picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Serum Levels of Sprifermin/FGF-18 | NA picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Serum Levels of Sprifermin/FGF-18 | NA picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Serum Levels of Sprifermin/FGF-18 | NA picogram/milliliter |
Secondary
Synovial Fluid Levels of Sprifermin/FGF-18
Levels of sprifermin/FGF-18 in synovial fluid were measured to provide a first estimate of the residence time of sprifermin in the synovial fluid.
Time frame: Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days)
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed are those who were evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 3 | 260.9 picogram/milliliter |
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 4 | 215.3 picogram/milliliter |
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 4 | 10670.0 picogram/milliliter |
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 2 | 202.5 picogram/milliliter |
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 3 | 463.7 picogram/milliliter |
| Placebo | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 1 | 622.1 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 3 | 8019.3 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 3 | 9592.2 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 3 | 8607.6 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 1 | 56876.4 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 1 | 3150.9 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 1 | 3628.3 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 4 | 7103.8 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 2 | 14756.3 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 4 | 9602.7 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 1 | 1006.5 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 3 | 4605.1 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 2 | 7039.1 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 2 | 6408.3 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 3 | 9443.4 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 1 | 4167.0 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 3 | 9422.2 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 1 | 1493.2 picogram/milliliter |
| Sprifermin (AS902330) 30 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 4 | 12458.4 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 1 | 1386.1 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 3 | 1801.0 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 4 | 331.1 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 1 | 467.9 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 3 | 3908.8 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 2 | 308.2 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 4 | 2285.2 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 3 | 16901.2 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 1 | 359.8 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 4 | 8026.4 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 2 | 7036.9 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 1 | 5896.4 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 1 | 1062.3 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 1 | 258.2 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 2 | 32360.2 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 2 | 1146.7 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 3 | 20753.0 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 3 | 10160.0 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 2; Cycle 3 | 4161.7 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 0; Cycle 4 | 22132.1 picogram/milliliter |
| Sprifermin (AS902330) 100 mcg- 4 Cycles | Synovial Fluid Levels of Sprifermin/FGF-18 | Week 1; Cycle 4 | 11468.3 picogram/milliliter |