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Trial record 1 of 1 for:    synv03809
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Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment (OASIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389452
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : May 21, 2015
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Drug: Synvisc-One
Enrollment 394
Recruitment Details The study was conducted at 36 sites in India between February 16, 2010 and September 7, 2011.
Pre-assignment Details  
Arm/Group Title Synvisc-One
Hide Arm/Group Description Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) 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 Western Ontario and McMaster Universities Osteoarthritis Index (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.
Period Title: Overall Study
Started 394
Participants Received Repeat Injection 11 [1]
Completed 369
Not Completed 25
Reason Not Completed
Lost to Follow-up             13
Adverse Event             1
Withdrawal by Subject             5
Enrolled but Not Eligible for Study             6
[1]
Repeat injection based on physician's assessment of efficacy and safety at Week 26, 39 or 52.
Arm/Group Title Synvisc-One
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 394
Hide Baseline Analysis Population Description
Intent to treat (ITT) population included all participants who received at least one dose of study medication.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 394 participants
57.6  (9.80)
[1]
Measure Description: Number of participants analysed for this parameter were 392.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 394 participants
Female
285
  72.3%
Male
109
  27.7%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 394 participants
70.72  (11.526)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 394 participants
160.11  (8.836)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 394 participants
27.66  (4.477)
1.Primary Outcome
Title Change From Baseline in WOMAC A1 Subscore at Week 26
Hide Description 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]).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 394
Mean (Standard Deviation)
Unit of Measure: units on a scale
-28.0  (19.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synvisc-One
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in WOMAC A1 Subscore at Week 52
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Mean (Standard Deviation)
Unit of Measure: units on a scale
-32.7  (19.95)
3.Secondary Outcome
Title Change From Baseline in WOMAC A Score at Week 52
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Mean (Standard Deviation)
Unit of Measure: units on a scale
-29.18  (19.158)
4.Secondary Outcome
Title Change From Baseline in WOMAC B Score at Week 52
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Mean (Standard Deviation)
Unit of Measure: units on a scale
-25.77  (22.047)
5.Secondary Outcome
Title Change From Baseline in WOMAC C Score at Week 52
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Mean (Standard Deviation)
Unit of Measure: units on a scale
-25.72  (19.449)
6.Secondary Outcome
Title Patient Global Assessment (PTGA) Score at Week 52
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Measure Type: Number
Unit of Measure: participants
Very well 82
Well 175
Fair 90
Poor 40
Very poor 1
7.Secondary Outcome
Title Clinician Observer Global Assessment (COGA) Score at Week 52
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 388
Measure Type: Number
Unit of Measure: participants
Very well 77
Well 177
Fair 98
Poor 35
Very poor 1
8.Secondary Outcome
Title 12-Item Short Form Health Survey (SF-12)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 394
Measure Type: Number
Unit of Measure: participants
Q1: Excellent/Very Good, Baseline 35
Q1: Excellent/Very Good, Week 26 87
Q1: Excellent/Very Good, Week 52 135
Q1: Good, Baseline 139
Q1: Good, Week 26 230
Q1: Good, Week 52 189
Q1: Fair/Poor, Baseline 219
Q1: Fair/Poor, Week 26 76
Q1: Fair/Poor, Week 52 64
Q1: Missing, Baseline 1
Q1: Missing, Week 26 1
Q1: Missing, Week 52 0
Q2a: Yes, Limited a Lot/a Little, Baseline 367
Q2a: Yes, Limited a Lot/a Little, Week 26 303
Q2a: Yes, Limited a Lot/a Little, Week 52 293
Q2a: No Not Limited at All, Baseline 24
Q2a: No Not Limited at All, Week 26 90
Q2a: No Not Limited at All, Week 52 95
Q2a: Missing, Baseline 3
Q2a: Missing, Week 26 1
Q2a: Missing, Week 52 0
Q2b: Yes, Limited a Lot/a Little, Baseline 373
Q2b: Yes, Limited a Lot/a Little, Week 26 338
Q2b: Yes, Limited a Lot/a Little, Week 52 334
Q2b: No Not Limited at All, Baseline 19
Q2b: No Not Limited at All, Week 26 55
Q2b: No Not Limited at All, Week 52 54
Q2b: Missing, Baseline 2
Q2b: Missing, Week 26 1
Q2b: Missing, Week 52 0
Q3a: All/Most of the Time, Baseline 152
Q3a: All/Most of the Time, Week 26 62
Q3a: All/Most of the Time, Week 52 76
Q3a: Some of the Time, Baseline 163
Q3a: Some of the Time, Week 26 170
Q3a: Some of the Time, Week 52 142
Q3a: A Little/None of the Time, Baseline 76
Q3a: A Little/None of the Time, Week 26 159
Q3a: A Little/None of the Time, Week 52 169
Q3a: Missing, Baseline 3
Q3a: Missing, Week 26 3
Q3a: Missing, Week 52 1
Q3b: All/Most of the Time, Baseline 137
Q3b: All/Most of the Time, Week 26 58
Q3b: All/Most of the Time, Week 52 57
Q3b: Some of the Time, Baseline 158
Q3b: Some of the Time, Week 26 147
Q3b: Some of the Time, Week 52 148
Q3b: A Little/None of the Time, Baseline 96
Q3b: A Little/None of the Time, Week 26 187
Q3b: A Little/None of the Time, Week 52 183
Q3b: Missing, Baseline 3
Q3b: Missing, Week 26 2
Q3b: Missing, Week 52 0
Q4a: All/Most of the Time, Baseline 114
Q4a: All/Most of the Time, Week 26 60
Q4a: All/Most of the Time, Week 52 58
Q4a: Some of the Time, Baseline 149
Q4a: Some of the Time, Week 26 115
Q4a: Some of the Time, Week 52 132
Q4a: A Little/None of the Time, Baseline 128
Q4a: A Little/None of the Time, Week 26 217
Q4a: A Little/None of the Time, Week 52 198
Q4a: Missing, Baseline 3
Q4a: Missing, Week 26 2
Q4a: Missing, Week 52 0
Q4b: All/Most of the Time, Baseline 88
Q4b: All/Most of the Time, Week 26 48
Q4b: All/Most of the Time, Week 52 56
Q4b: Some of the Time, Baseline 166
Q4b: Some of the Time, Week 26 131
Q4b: Some of the Time, Week 52 128
Q4b: A Little/None of the Time, Baseline 137
Q4b: A Little/None of the Time, Week 26 213
Q4b: A Little/None of the Time, Week 52 204
Q4b: Missing, Baseline 3
Q4b: Missing, Week 26 2
Q4b: Missing, Week 52 0
Q5: Not at All/A Little Bit, Baseline 70
Q5: Not at All/A Little Bit, Week 26 207
Q5: Not at All/A Little Bit, Week 52 219
Q5: Moderately, Baseline 182
Q5: Moderately, Week 26 122
Q5: Moderately, Week 52 105
Q5: Quite a Bit/Extremely, Baseline 140
Q5: Quite a Bit/Extremely, Week 26 63
Q5: Quite a Bit/Extremely, Week 52 64
Q5: Missing, Baseline 2
Q5: Missing, Week 26 2
Q5: Missing, Week 52 0
Q6a: All/Most of the Time, Baseline 188
Q6a: All/Most of the Time, Week 26 240
Q6a: All/Most of the Time, Week 52 244
Q6a: Some of the Time, Baseline 112
Q6a: Some of the Time, Week 26 106
Q6a: Some of the Time, Week 52 121
Q6a: A Little/None of the Time, Baseline 92
Q6a: A Little/None of the Time, Week 26 46
Q6a: A Little/None of the Time, Week 52 23
Q6a: Missing, Baseline 2
Q6a: Missing, Week 26 2
Q6a: Missing, Week 52 0
Q6b: All/Most of the Time, Baseline 122
Q6b: All/Most of the Time, Week 26 190
Q6b: All/Most of the Time, Week 52 215
Q6b: Some of the Time, Baseline 154
Q6b: Some of the Time, Week 26 134
Q6b: Some of the Time, Week 52 132
Q6b: A Little/None of the Time, Baseline 115
Q6b: A Little/None of the Time, Week 26 67
Q6b: A Little/None of the Time, Week 52 40
Q6b: Missing, Baseline 3
Q6b: Missing, Week 26 3
Q6b: Missing, Week 52 1
Q6c: All/Most of the Time, Baseline 67
Q6c: All/Most of the Time, Week 26 28
Q6c: All/Most of the Time, Week 52 53
Q6c: Some of the Time, Baseline 162
Q6c: Some of the Time, Week 26 102
Q6c: Some of the Time, Week 52 107
Q6c: A Little/None of the Time, Baseline 159
Q6c: A Little/None of the Time, Week 26 261
Q6c: A Little/None of the Time, Week 52 227
Q6c: Missing, Baseline 6
Q6c: Missing, Week 26 3
Q6c: Missing, Week 52 1
Q7: All/Most of the Time, Baseline 116
Q7: All/Most of the Time, Week 26 35
Q7: All/Most of the Time, Week 52 43
Q7: Some of the Time, Baseline 166
Q7: Some of the Time, Week 26 129
Q7: Some of the Time, Week 52 119
Q7: A Little/None of the Time, Baseline 110
Q7: A Little/None of the Time, Week 26 228
Q7: A Little/None of the Time, Week 52 226
Q7: Missing, Baseline 2
Q7: Missing, Week 26 2
Q7: Missing, Week 52 0
9.Secondary Outcome
Title Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analysed = participants with baseline and Week 52 data.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 369
Measure Type: Number
Unit of Measure: participants
Increased Therapy 5
Decreased Therapy 2
No Change in Therapy 362
10.Secondary Outcome
Title Time Between Initial and Repeat Synvisc-One Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analysed = participants from ITT population who received repeat injection.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: weeks
38.31  (13.403)
11.Secondary Outcome
Title Change From Baseline in WOMAC A1 Subscore After Repeat Injection
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 After Repeat Injection -12.4  (15.32)
Week 4 After Repeat Injection -10.1  (13.05)
12.Secondary Outcome
Title Change From Baseline in WOMAC A Score After Repeat Injection
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 After Repeat Injection -4.04  (10.571)
Week 4 After Repeat Injection -3.05  (13.473)
13.Secondary Outcome
Title Change From Baseline in WOMAC B Score After Repeat Injection
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Repeat intent to treat population.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 After Repeat Injection -6.14  (6.034)
Week 4 After Repeat Injection -3.23  (12.009)
14.Secondary Outcome
Title Change From Baseline in WOMAC C Score After Repeat Injection
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Repeat intent to treat population.
Arm/Group Title Synvisc-One
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 After Repeat Injection -4.08  (7.578)
Week 4 After Repeat Injection -4.66  (6.005)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final follow up visit (up to Week 56) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the ‘on treatment period’ (From First dose of study drug until the end of study period). Analysis performed on safety population included all participants treated in the study. Data was planned to be reported for systemic and local adverse events separately.
 
Arm/Group Title Synvisc-One: Systemic Adverse Event Synvisc-One: Local Adverse Event
Hide Arm/Group Description 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.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint. 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. Local adverse events were defined as any adverse event which occurred in the treated joint.
All-Cause Mortality
Synvisc-One: Systemic Adverse Event Synvisc-One: Local Adverse Event
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Synvisc-One: Systemic Adverse Event Synvisc-One: Local Adverse Event
Affected / at Risk (%) Affected / at Risk (%)
Total   5/394 (1.27%)   1/394 (0.25%) 
Cardiac disorders     
Cardiac arrest  1  1/394 (0.25%)  0/394 (0.00%) 
Coronary artery disease  1  1/394 (0.25%)  0/394 (0.00%) 
Infections and infestations     
Influenza  1  1/394 (0.25%)  0/394 (0.00%) 
Urinary tract infection  1  1/394 (0.25%)  0/394 (0.00%) 
Musculoskeletal and connective tissue disorders     
Cervical spinal stenosis  1  1/394 (0.25%)  0/394 (0.00%) 
Intervertebral disc protrusion  1  1/394 (0.25%)  0/394 (0.00%) 
Arthritis  1  0/394 (0.00%)  1/394 (0.25%) 
Nervous system disorders     
Cervical myelopathy  1  1/394 (0.25%)  0/394 (0.00%) 
Myelomalacia  1  1/394 (0.25%)  0/394 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Synvisc-One: Systemic Adverse Event Synvisc-One: Local Adverse Event
Affected / at Risk (%) Affected / at Risk (%)
Total   23/394 (5.84%)   22/394 (5.58%) 
Gastrointestinal disorders     
Constipation  1  1/394 (0.25%)  0/394 (0.00%) 
Vomiting  1  1/394 (0.25%)  0/394 (0.00%) 
General disorders     
Oedema peripheral  1  4/394 (1.02%)  0/394 (0.00%) 
Pain  1  2/394 (0.51%)  0/394 (0.00%) 
Pyrexia  1  2/394 (0.51%)  0/394 (0.00%) 
Injection site pain  1  0/394 (0.00%)  1/394 (0.25%) 
Injection site pruritus  1  0/394 (0.00%)  1/394 (0.25%) 
Infections and infestations     
Cellulitis  1  1/394 (0.25%)  0/394 (0.00%) 
Influenza  1  3/394 (0.76%)  0/394 (0.00%) 
Injury, poisoning and procedural complications     
Ligament sprain  1  1/394 (0.25%)  0/394 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/394 (0.51%)  16/394 (4.06%) 
Back pain  1  3/394 (0.76%)  0/394 (0.00%) 
Myalgia  1  2/394 (0.51%)  0/394 (0.00%) 
Neck pain  1  1/394 (0.25%)  0/394 (0.00%) 
Pain in extremity  1  4/394 (1.02%)  0/394 (0.00%) 
Synovitis  1  0/394 (0.00%)  4/394 (1.02%) 
Bursitis  1  0/394 (0.00%)  1/394 (0.25%) 
Musculoskeletal stiffness  1  0/394 (0.00%)  1/394 (0.25%) 
Nervous system disorders     
Head discomfort  1  1/394 (0.25%)  0/394 (0.00%) 
Headache  1  1/394 (0.25%)  0/394 (0.00%) 
Radiculopathy  1  1/394 (0.25%)  0/394 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/394 (0.25%)  0/394 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/394 (0.25%)  0/394 (0.00%) 
Skin hyperpigmentation  1  1/394 (0.25%)  0/394 (0.00%) 
Swelling face  1  1/394 (0.25%)  0/394 (0.00%) 
Urticaria  1  1/394 (0.25%)  0/394 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact ­-US@Sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02389452    
Other Study ID Numbers: SYNV03809
U1111-1167-6813 ( Other Identifier: World Health Organization )
First Submitted: March 4, 2015
First Posted: March 17, 2015
Results First Submitted: May 5, 2015
Results First Posted: May 21, 2015
Last Update Posted: August 7, 2017