Osteoarthritis
Conditions
Brief summary
Primary Objective: To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s). Secondary Objective: To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
Detailed description
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
Interventions
DRUGSynvisc-One
intraarticular injection
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female participant aged 30 years or older, with active lifestyle. * The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations. * The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence \[KL\] Grade I-III), predominant in the tibiofemoral compartment. * WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee. * Participants with bilateral disease may be included in the study with the below strict conditions: * Only one knee included in the efficacy assessment and considered the target knee (the worst knee by the WOMAC A1 pain scale should be selected). The selected knee must meet the inclusion and
Exclusion criteria
. * The non-target knee may also be treated with Synvisc-One and does not need to meet the KL grade knee specific inclusion criteria described above. The other criteria do apply. * If female, must had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must had been surgically sterile or postmenopausal (as documented in the medical history) for at least 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC A1 Subscore at Week 26 | Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]). | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC A1 Subscore at Week 52 | Baseline, Week 52 (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. |
| Change From Baseline in WOMAC B Score at Week 52 | Baseline, Week 52 (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. |
| Change From Baseline in WOMAC C Score at Week 52 | Baseline, Week 52 (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Patient Global Assessment (PTGA) Score at Week 52 | Week 52 (missing data imputed by LOCF) | PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported. |
| Clinician Observer Global Assessment (COGA) Score at Week 52 | Week 52 (missing data imputed by LOCF). | COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported. |
| 12-Item Short Form Health Survey (SF-12) | Baseline, Week 26, 52 | SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported. |
| Change From Baseline in WOMAC A Score at Week 52 | Baseline, Week 52 (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. |
| Time Between Initial and Repeat Synvisc-One Treatment | Baseline up to Week 52 | Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection. |
| Change From Baseline in WOMAC A1 Subscore After Repeat Injection | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). |
| Change From Baseline in WOMAC A Score After Repeat Injection | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). |
| Change From Baseline in WOMAC B Score After Repeat Injection | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). |
| Change From Baseline in WOMAC C Score After Repeat Injection | Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF) | WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52). |
| Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | Baseline up to Week 52 | Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported. |
Participant flow
Recruitment details
The study was conducted at 36 sites in India between February 16, 2010 and September 7, 2011.
Participants by arm
| Arm | Count |
|---|---|
| Synvisc-One Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. | 394 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Enrolled but Not Eligible for Study | 6 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Synvisc-One |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 9.8 |
| Body Mass Index | 27.66 kilogram per square meter STANDARD_DEVIATION 4.477 |
| Height | 160.11 centimeters STANDARD_DEVIATION 8.836 |
| Sex: Female, Male Female | 285 Participants |
| Sex: Female, Male Male | 109 Participants |
| Weight | 70.72 kilograms STANDARD_DEVIATION 11.526 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 394 | 22 / 394 |
| serious Total, serious adverse events | 5 / 394 | 1 / 394 |
Outcome results
Primary
Change From Baseline in WOMAC A1 Subscore at Week 26
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
Time frame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC A1 Subscore at Week 26 | -28.0 units on a scale | Standard Deviation 19.89 |
p-value: <0.0001Paired t-test
Secondary
12-Item Short Form Health Survey (SF-12)
SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.
Time frame: Baseline, Week 26, 52
Population: ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Good, Week 52 | 189 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Excellent/Very Good, Baseline | 35 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Excellent/Very Good, Week 26 | 87 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Excellent/Very Good, Week 52 | 135 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Good, Baseline | 139 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Good, Week 26 | 230 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Fair/Poor, Baseline | 219 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Fair/Poor, Week 26 | 76 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Fair/Poor, Week 52 | 64 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Missing, Baseline | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Missing, Week 26 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q1: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Yes, Limited a Lot/a Little, Baseline | 367 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Yes, Limited a Lot/a Little, Week 26 | 303 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Yes, Limited a Lot/a Little, Week 52 | 293 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: No Not Limited at All, Baseline | 24 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: No Not Limited at All, Week 26 | 90 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: No Not Limited at All, Week 52 | 95 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Missing, Week 26 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2a: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Yes, Limited a Lot/a Little, Baseline | 373 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Yes, Limited a Lot/a Little, Week 26 | 338 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Yes, Limited a Lot/a Little, Week 52 | 334 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: No Not Limited at All, Baseline | 19 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: No Not Limited at All, Week 26 | 55 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: No Not Limited at All, Week 52 | 54 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Missing, Baseline | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Missing, Week 26 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q2b: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: All/Most of the Time, Baseline | 152 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: All/Most of the Time, Week 26 | 62 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: All/Most of the Time, Week 52 | 76 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Some of the Time, Baseline | 163 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Some of the Time, Week 26 | 170 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Some of the Time, Week 52 | 142 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: A Little/None of the Time, Baseline | 76 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: A Little/None of the Time, Week 26 | 159 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: A Little/None of the Time, Week 52 | 169 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Missing, Week 26 | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3a: Missing, Week 52 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: All/Most of the Time, Baseline | 137 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: All/Most of the Time, Week 26 | 58 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: All/Most of the Time, Week 52 | 57 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Some of the Time, Baseline | 158 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Some of the Time, Week 26 | 147 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Some of the Time, Week 52 | 148 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: A Little/None of the Time, Baseline | 96 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: A Little/None of the Time, Week 26 | 187 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: A Little/None of the Time, Week 52 | 183 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q3b: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: All/Most of the Time, Baseline | 114 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: All/Most of the Time, Week 26 | 60 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: All/Most of the Time, Week 52 | 58 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Some of the Time, Baseline | 149 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Some of the Time, Week 26 | 115 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Some of the Time, Week 52 | 132 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: A Little/None of the Time, Baseline | 128 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: A Little/None of the Time, Week 26 | 217 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: A Little/None of the Time, Week 52 | 198 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4a: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: All/Most of the Time, Baseline | 88 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: All/Most of the Time, Week 26 | 48 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: All/Most of the Time, Week 52 | 56 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Some of the Time, Baseline | 166 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Some of the Time, Week 26 | 131 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Some of the Time, Week 52 | 128 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: A Little/None of the Time, Baseline | 137 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: A Little/None of the Time, Week 26 | 213 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: A Little/None of the Time, Week 52 | 204 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q4b: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Not at All/A Little Bit, Baseline | 70 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Not at All/A Little Bit, Week 26 | 207 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Not at All/A Little Bit, Week 52 | 219 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Moderately, Baseline | 182 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Moderately, Week 26 | 122 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Moderately, Week 52 | 105 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Quite a Bit/Extremely, Baseline | 140 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Quite a Bit/Extremely, Week 26 | 63 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Quite a Bit/Extremely, Week 52 | 64 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Missing, Baseline | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q5: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: All/Most of the Time, Baseline | 188 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: All/Most of the Time, Week 26 | 240 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: All/Most of the Time, Week 52 | 244 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Some of the Time, Baseline | 112 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Some of the Time, Week 26 | 106 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Some of the Time, Week 52 | 121 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: A Little/None of the Time, Baseline | 92 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: A Little/None of the Time, Week 26 | 46 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: A Little/None of the Time, Week 52 | 23 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Missing, Baseline | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6a: Missing, Week 52 | 0 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: All/Most of the Time, Baseline | 122 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: All/Most of the Time, Week 26 | 190 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: All/Most of the Time, Week 52 | 215 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Some of the Time, Baseline | 154 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Some of the Time, Week 26 | 134 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Some of the Time, Week 52 | 132 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: A Little/None of the Time, Baseline | 115 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: A Little/None of the Time, Week 26 | 67 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: A Little/None of the Time, Week 52 | 40 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Missing, Baseline | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Missing, Week 26 | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6b: Missing, Week 52 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: All/Most of the Time, Baseline | 67 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: All/Most of the Time, Week 26 | 28 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: All/Most of the Time, Week 52 | 53 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Some of the Time, Baseline | 162 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Some of the Time, Week 26 | 102 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Some of the Time, Week 52 | 107 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: A Little/None of the Time, Baseline | 159 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: A Little/None of the Time, Week 26 | 261 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: A Little/None of the Time, Week 52 | 227 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Missing, Baseline | 6 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Missing, Week 26 | 3 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q6c: Missing, Week 52 | 1 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: All/Most of the Time, Baseline | 116 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: All/Most of the Time, Week 26 | 35 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: All/Most of the Time, Week 52 | 43 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Some of the Time, Baseline | 166 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Some of the Time, Week 26 | 129 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Some of the Time, Week 52 | 119 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: A Little/None of the Time, Baseline | 110 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: A Little/None of the Time, Week 26 | 228 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: A Little/None of the Time, Week 52 | 226 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Missing, Baseline | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Missing, Week 26 | 2 participants |
| Synvisc-One | 12-Item Short Form Health Survey (SF-12) | Q7: Missing, Week 52 | 0 participants |
Secondary
Change From Baseline in WOMAC A1 Subscore After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Population: Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC A1 Subscore After Repeat Injection | Week 1 After Repeat Injection | -12.4 units on a scale | Standard Deviation 15.32 |
| Synvisc-One | Change From Baseline in WOMAC A1 Subscore After Repeat Injection | Week 4 After Repeat Injection | -10.1 units on a scale | Standard Deviation 13.05 |
Secondary
Change From Baseline in WOMAC A1 Subscore at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC A1 Subscore at Week 52 | -32.7 units on a scale | Standard Deviation 19.95 |
Secondary
Change From Baseline in WOMAC A Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Population: Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC A Score After Repeat Injection | Week 1 After Repeat Injection | -4.04 units on a scale | Standard Deviation 10.571 |
| Synvisc-One | Change From Baseline in WOMAC A Score After Repeat Injection | Week 4 After Repeat Injection | -3.05 units on a scale | Standard Deviation 13.473 |
Secondary
Change From Baseline in WOMAC A Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC A Score at Week 52 | -29.18 units on a scale | Standard Deviation 19.158 |
Secondary
Change From Baseline in WOMAC B Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Population: Repeat intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC B Score After Repeat Injection | Week 1 After Repeat Injection | -6.14 units on a scale | Standard Deviation 6.034 |
| Synvisc-One | Change From Baseline in WOMAC B Score After Repeat Injection | Week 4 After Repeat Injection | -3.23 units on a scale | Standard Deviation 12.009 |
Secondary
Change From Baseline in WOMAC B Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC B Score at Week 52 | -25.77 units on a scale | Standard Deviation 22.047 |
Secondary
Change From Baseline in WOMAC C Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Population: Repeat intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC C Score After Repeat Injection | Week 1 After Repeat Injection | -4.08 units on a scale | Standard Deviation 7.578 |
| Synvisc-One | Change From Baseline in WOMAC C Score After Repeat Injection | Week 4 After Repeat Injection | -4.66 units on a scale | Standard Deviation 6.005 |
Secondary
Change From Baseline in WOMAC C Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Change From Baseline in WOMAC C Score at Week 52 | -25.72 units on a scale | Standard Deviation 19.449 |
Secondary
Clinician Observer Global Assessment (COGA) Score at Week 52
COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.
Time frame: Week 52 (missing data imputed by LOCF).
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc-One | Clinician Observer Global Assessment (COGA) Score at Week 52 | Very well | 77 participants |
| Synvisc-One | Clinician Observer Global Assessment (COGA) Score at Week 52 | Well | 177 participants |
| Synvisc-One | Clinician Observer Global Assessment (COGA) Score at Week 52 | Fair | 98 participants |
| Synvisc-One | Clinician Observer Global Assessment (COGA) Score at Week 52 | Poor | 35 participants |
| Synvisc-One | Clinician Observer Global Assessment (COGA) Score at Week 52 | Very poor | 1 participants |
Secondary
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.
Time frame: Baseline up to Week 52
Population: ITT population. Number of participants analysed = participants with baseline and Week 52 data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc-One | Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | Increased Therapy | 5 participants |
| Synvisc-One | Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | Decreased Therapy | 2 participants |
| Synvisc-One | Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52 | No Change in Therapy | 362 participants |
Secondary
Patient Global Assessment (PTGA) Score at Week 52
PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.
Time frame: Week 52 (missing data imputed by LOCF)
Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synvisc-One | Patient Global Assessment (PTGA) Score at Week 52 | Very well | 82 participants |
| Synvisc-One | Patient Global Assessment (PTGA) Score at Week 52 | Well | 175 participants |
| Synvisc-One | Patient Global Assessment (PTGA) Score at Week 52 | Fair | 90 participants |
| Synvisc-One | Patient Global Assessment (PTGA) Score at Week 52 | Poor | 40 participants |
| Synvisc-One | Patient Global Assessment (PTGA) Score at Week 52 | Very poor | 1 participants |
Secondary
Time Between Initial and Repeat Synvisc-One Treatment
Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.
Time frame: Baseline up to Week 52
Population: ITT population. Number of participants analysed = participants from ITT population who received repeat injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc-One | Time Between Initial and Repeat Synvisc-One Treatment | 38.31 weeks | Standard Deviation 13.403 |