Trial Outcomes & Findings for Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA (NCT NCT02110238)
NCT ID: NCT02110238
Last Updated: 2021-03-09
Results Overview
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
421 participants
Primary outcome timeframe
Change from Baseline (CFB) over Weeks 3, 6, and 12
Results posted on
2021-03-09
Participant Flow
29 outpatient medical clinics enrolled subjects over 4.5 months
Participant milestones
| Measure |
Euflexxa
Euflexxa® (hyaluronic acid of bacterial origin)
Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
SUPARTZ® (hyaluronic acid of avian origin)
Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
|---|---|---|
|
12 Week Pivotal Phase
STARTED
|
212
|
209
|
|
12 Week Pivotal Phase
COMPLETED
|
202
|
200
|
|
12 Week Pivotal Phase
NOT COMPLETED
|
10
|
9
|
|
14 Week Blinded Extension Phase
STARTED
|
202
|
200
|
|
14 Week Blinded Extension Phase
COMPLETED
|
190
|
188
|
|
14 Week Blinded Extension Phase
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Euflexxa
Euflexxa® (hyaluronic acid of bacterial origin)
Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
SUPARTZ® (hyaluronic acid of avian origin)
Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
|---|---|---|
|
12 Week Pivotal Phase
Adverse Event
|
3
|
0
|
|
12 Week Pivotal Phase
Lack of Efficacy
|
2
|
3
|
|
12 Week Pivotal Phase
Lost to Follow-up
|
2
|
0
|
|
12 Week Pivotal Phase
Physician Decision
|
0
|
2
|
|
12 Week Pivotal Phase
Protocol Violation
|
0
|
1
|
|
12 Week Pivotal Phase
Withdrawal by Subject
|
3
|
3
|
|
14 Week Blinded Extension Phase
Adverse Event
|
1
|
1
|
|
14 Week Blinded Extension Phase
Lack of Efficacy
|
2
|
4
|
|
14 Week Blinded Extension Phase
Lost to Follow-up
|
3
|
1
|
|
14 Week Blinded Extension Phase
Protocol Violation
|
2
|
3
|
|
14 Week Blinded Extension Phase
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA
Baseline characteristics by cohort
| Measure |
Euflexxa
n=211 Participants
Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
n=209 Participants
SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline (CFB) over Weeks 3, 6, and 12Population: Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.
Outcome measures
| Measure |
Euflexxa
n=189 Participants
Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
n=195 Participants
SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
|---|---|---|
|
WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
|
30.15 millimeter
Interval 27.59 to 32.71
|
26.85 millimeter
Interval 24.35 to 29.35
|
Adverse Events
Euflexxa
Serious events: 6 serious events
Other events: 59 other events
Deaths: 0 deaths
Supartz
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Euflexxa
n=211 participants at risk
Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
n=209 participants at risk
SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Gastrointestinal disorders
Internal hernia
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/211 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.48%
1/209 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Infections and infestations
Acute sinusitis
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Injury, poisoning and procedural complications
Pneumothorax tramatic
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/211 • Number of events 1 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
0.00%
0/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
Other adverse events
| Measure |
Euflexxa
n=211 participants at risk
Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
Supartz
n=209 participants at risk
SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
24/211 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
11.0%
23/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
10/211 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
7.2%
15/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
|
Nervous system disorders
Headache
|
11.8%
25/211 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
10.5%
22/209 • 26 Weeks (12 week primary period plus 14 week extension phase)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place