Trial Outcomes & Findings for 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 (NCT NCT02389452)
NCT ID: NCT02389452
Last Updated: 2017-08-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
394 participants
Primary outcome timeframe
Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).
Results posted on
2017-08-07
Participant Flow
The study was conducted at 36 sites in India between February 16, 2010 and September 7, 2011.
Participant milestones
| Measure |
Synvisc-One
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.
|
|---|---|
|
Overall Study
STARTED
|
394
|
|
Overall Study
Participants Received Repeat Injection
|
11
|
|
Overall Study
COMPLETED
|
369
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Synvisc-One
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Enrolled but Not Eligible for Study
|
6
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Synvisc-One
n=394 Participants
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.
|
|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
|
Weight
|
70.72 kilograms
STANDARD_DEVIATION 11.526 • n=5 Participants
|
|
Height
|
160.11 centimeters
STANDARD_DEVIATION 8.836 • n=5 Participants
|
|
Body Mass Index
|
27.66 kilogram per square meter
STANDARD_DEVIATION 4.477 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).Population: ITT population.
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.
Outcome measures
| Measure |
Synvisc-One
n=394 Participants
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.
|
|---|---|
|
Change From Baseline in WOMAC A1 Subscore at Week 26
|
-28.0 units on a scale
Standard Deviation 19.89
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (missing data imputed by LOCF)Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Change From Baseline in WOMAC A1 Subscore at Week 52
|
-32.7 units on a scale
Standard Deviation 19.95
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (missing data imputed by LOCF)Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Change From Baseline in WOMAC A Score at Week 52
|
-29.18 units on a scale
Standard Deviation 19.158
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (missing data imputed by LOCF)Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Change From Baseline in WOMAC B Score at Week 52
|
-25.77 units on a scale
Standard Deviation 22.047
|
SECONDARY outcome
Timeframe: Baseline, Week 52 (missing data imputed by LOCF)Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Change From Baseline in WOMAC C Score at Week 52
|
-25.72 units on a scale
Standard Deviation 19.449
|
SECONDARY outcome
Timeframe: Week 52 (missing data imputed by LOCF)Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Patient Global Assessment (PTGA) Score at Week 52
Very well
|
82 participants
|
|
Patient Global Assessment (PTGA) Score at Week 52
Well
|
175 participants
|
|
Patient Global Assessment (PTGA) Score at Week 52
Fair
|
90 participants
|
|
Patient Global Assessment (PTGA) Score at Week 52
Poor
|
40 participants
|
|
Patient Global Assessment (PTGA) Score at Week 52
Very poor
|
1 participants
|
SECONDARY outcome
Timeframe: Week 52 (missing data imputed by LOCF).Population: ITT population. Number of participants analyzed=participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=388 Participants
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.
|
|---|---|
|
Clinician Observer Global Assessment (COGA) Score at Week 52
Very well
|
77 participants
|
|
Clinician Observer Global Assessment (COGA) Score at Week 52
Well
|
177 participants
|
|
Clinician Observer Global Assessment (COGA) Score at Week 52
Fair
|
98 participants
|
|
Clinician Observer Global Assessment (COGA) Score at Week 52
Poor
|
35 participants
|
|
Clinician Observer Global Assessment (COGA) Score at Week 52
Very poor
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26, 52Population: ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.
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.
Outcome measures
| Measure |
Synvisc-One
n=394 Participants
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.
|
|---|---|
|
12-Item Short Form Health Survey (SF-12)
Q4a: All/Most of the Time, Baseline
|
114 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: All/Most of the Time, Week 26
|
60 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: All/Most of the Time, Week 52
|
58 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Some of the Time, Baseline
|
149 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Some of the Time, Week 52
|
132 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: A Little/None of the Time, Baseline
|
128 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: A Little/None of the Time, Week 26
|
217 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: All/Most of the Time, Baseline
|
88 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: All/Most of the Time, Week 52
|
56 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: A Little/None of the Time, Baseline
|
137 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: A Little/None of the Time, Week 26
|
213 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: All/Most of the Time, Baseline
|
122 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Some of the Time, Week 26
|
134 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Some of the Time, Week 52
|
107 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: A Little/None of the Time, Week 26
|
261 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: A Little/None of the Time, Week 52
|
227 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Missing, Baseline
|
6 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Missing, Week 52
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: All/Most of the Time, Baseline
|
116 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: All/Most of the Time, Week 26
|
35 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: All/Most of the Time, Week 52
|
43 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Some of the Time, Baseline
|
166 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Some of the Time, Week 26
|
129 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Some of the Time, Week 52
|
119 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: A Little/None of the Time, Baseline
|
110 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: A Little/None of the Time, Week 26
|
228 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: A Little/None of the Time, Week 52
|
226 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Missing, Baseline
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q7: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: A Little/None of the Time, Week 26
|
187 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Not at All/A Little Bit, Week 52
|
219 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Some of the Time, Week 26
|
115 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: A Little/None of the Time, Week 52
|
198 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4a: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Some of the Time, Week 26
|
147 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Some of the Time, Week 52
|
148 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: A Little/None of the Time, Baseline
|
96 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: A Little/None of the Time, Week 52
|
183 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: All/Most of the Time, Week 26
|
48 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Some of the Time, Baseline
|
166 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Some of the Time, Week 26
|
131 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Some of the Time, Week 52
|
128 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Moderately, Baseline
|
182 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Moderately, Week 26
|
122 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: A Little/None of the Time, Week 52
|
204 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Moderately, Week 52
|
105 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Quite a Bit/Extremely, Baseline
|
140 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Quite a Bit/Extremely, Week 26
|
63 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q4b: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Not at All/A Little Bit, Baseline
|
70 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Not at All/A Little Bit, Week 26
|
207 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: A Little/None of the Time, Week 52
|
23 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Quite a Bit/Extremely, Week 52
|
64 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Missing, Baseline
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q5: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: All/Most of the Time, Baseline
|
188 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: All/Most of the Time, Week 26
|
240 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: All/Most of the Time, Week 52
|
244 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Some of the Time, Baseline
|
112 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Some of the Time, Week 26
|
106 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Some of the Time, Week 52
|
121 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: A Little/None of the Time, Baseline
|
92 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: A Little/None of the Time, Week 26
|
46 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Missing, Baseline
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Fair/Poor, Week 26
|
76 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Fair/Poor, Week 52
|
64 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Missing, Baseline
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Missing, Week 26
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Yes, Limited a Lot/a Little, Baseline
|
367 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Yes, Limited a Lot/a Little, Week 26
|
303 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Yes, Limited a Lot/a Little, Week 52
|
293 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: No Not Limited at All, Baseline
|
24 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: No Not Limited at All, Week 26
|
90 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: No Not Limited at All, Week 52
|
95 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Missing, Week 26
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2a: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Yes, Limited a Lot/a Little, Baseline
|
373 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Missing, Week 26
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Excellent/Very Good, Baseline
|
35 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Excellent/Very Good, Week 26
|
87 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Excellent/Very Good, Week 52
|
135 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Good, Baseline
|
139 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Good, Week 26
|
230 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Good, Week 52
|
189 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q1: Fair/Poor, Baseline
|
219 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Yes, Limited a Lot/a Little, Week 26
|
338 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Yes, Limited a Lot/a Little, Week 52
|
334 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: No Not Limited at All, Baseline
|
19 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: No Not Limited at All, Week 26
|
55 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: No Not Limited at All, Week 52
|
54 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Missing, Baseline
|
2 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Missing, Week 26
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q2b: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: All/Most of the Time, Baseline
|
152 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: All/Most of the Time, Week 26
|
62 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: All/Most of the Time, Week 52
|
76 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Some of the Time, Baseline
|
163 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Some of the Time, Week 26
|
170 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Some of the Time, Week 52
|
142 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: A Little/None of the Time, Baseline
|
76 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: A Little/None of the Time, Week 26
|
159 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: A Little/None of the Time, Week 52
|
169 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Missing, Week 26
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3a: Missing, Week 52
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: All/Most of the Time, Baseline
|
137 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: All/Most of the Time, Week 26
|
58 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: All/Most of the Time, Week 52
|
57 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q3b: Some of the Time, Baseline
|
158 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6a: Missing, Week 52
|
0 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: All/Most of the Time, Week 26
|
190 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: All/Most of the Time, Week 52
|
215 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Some of the Time, Baseline
|
154 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Some of the Time, Week 52
|
132 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: A Little/None of the Time, Baseline
|
115 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: A Little/None of the Time, Week 26
|
67 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: A Little/None of the Time, Week 52
|
40 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Missing, Baseline
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Missing, Week 26
|
3 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6b: Missing, Week 52
|
1 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: All/Most of the Time, Baseline
|
67 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: All/Most of the Time, Week 26
|
28 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: All/Most of the Time, Week 52
|
53 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Some of the Time, Baseline
|
162 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Some of the Time, Week 26
|
102 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: A Little/None of the Time, Baseline
|
159 participants
|
|
12-Item Short Form Health Survey (SF-12)
Q6c: Missing, Week 26
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: ITT population. Number of participants analysed = participants with baseline and Week 52 data.
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.
Outcome measures
| Measure |
Synvisc-One
n=369 Participants
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.
|
|---|---|
|
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
Increased Therapy
|
5 participants
|
|
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
Decreased Therapy
|
2 participants
|
|
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
No Change in Therapy
|
362 participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: ITT population. Number of participants analysed = participants from ITT population who received repeat injection.
Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.
Outcome measures
| Measure |
Synvisc-One
n=11 Participants
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.
|
|---|---|
|
Time Between Initial and Repeat Synvisc-One Treatment
|
38.31 weeks
Standard Deviation 13.403
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Synvisc-One
n=11 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Synvisc-One
n=11 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)Population: Repeat intent to treat population.
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).
Outcome measures
| Measure |
Synvisc-One
n=11 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)Population: Repeat intent to treat population.
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).
Outcome measures
| Measure |
Synvisc-One
n=11 Participants
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.
|
|---|---|
|
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
|
|
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
|
Adverse Events
Synvisc-One: Systemic Adverse Event
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Synvisc-One: Local Adverse Event
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synvisc-One: Systemic Adverse Event
n=394 participants at risk
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.
|
Synvisc-One: Local Adverse Event
n=394 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Infections and infestations
Influenza
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Nervous system disorders
Cervical myelopathy
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Nervous system disorders
Myelomalacia
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/394 • 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.
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.
|
0.25%
1/394 • 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.
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.
|
Other adverse events
| Measure |
Synvisc-One: Systemic Adverse Event
n=394 participants at risk
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.
|
Synvisc-One: Local Adverse Event
n=394 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
General disorders
Oedema peripheral
|
1.0%
4/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
General disorders
Pain
|
0.51%
2/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
General disorders
Pyrexia
|
0.51%
2/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Infections and infestations
Influenza
|
0.76%
3/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
2/394 • 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.
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.
|
4.1%
16/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
3/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.51%
2/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
4/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Nervous system disorders
Head discomfort
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Nervous system disorders
Headache
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Nervous system disorders
Radiculopathy
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
1/394 • 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.
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.
|
0.00%
0/394 • 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.
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.
|
|
General disorders
Injection site pain
|
0.00%
0/394 • 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.
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.
|
0.25%
1/394 • 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.
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.
|
|
General disorders
Injection site pruritus
|
0.00%
0/394 • 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.
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.
|
0.25%
1/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/394 • 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.
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.
|
1.0%
4/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/394 • 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.
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.
|
0.25%
1/394 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/394 • 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.
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.
|
0.25%
1/394 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER