Osteoarthritis
Conditions
Keywords
osteoarthritis, knee pain, Supartz, Euflexxa, HA, hyaluronic acid
Brief summary
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.
Detailed description
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12. Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.
Interventions
DEVICESupartz
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
DEVICEEuflexxa
Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
Sponsors
Seikagaku Corporation
Bioventus LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria. * Symptoms in study knee for at least one year prior to the screening visit * Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity. * Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.
Exclusion criteria
* Inability to perform a 50 foot walk test. * Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections. * Prior hyaluronic acid injections into the study knee within six months of the screening visit. * Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation. * History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit. * Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap). * Subjects with clinically diagnosed symptomatic OA of the hip.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline | Change from Baseline (CFB) over Weeks 3, 6, and 12 | 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. |
Countries
United States
Participant flow
Recruitment details
29 outpatient medical clinics enrolled subjects over 4.5 months
Participants by arm
| Arm | Count |
|---|---|
| Euflexxa Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2. | 211 |
| Supartz SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2. | 209 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Euflexxa | Supartz | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 9.33 | 59.3 years STANDARD_DEVIATION 9.3 | 60.1 years STANDARD_DEVIATION 9.34 |
| Sex: Female, Male Female | 135 Participants | 138 Participants | 273 Participants |
| Sex: Female, Male Male | 76 Participants | 71 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 59 / 211 | 60 / 209 |
| serious Total, serious adverse events | 6 / 211 | 1 / 209 |
Outcome results
Primary
WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
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.
Time frame: Change from Baseline (CFB) over Weeks 3, 6, and 12
Population: Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Euflexxa | WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline | 30.15 millimeter |
| Supartz | WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline | 26.85 millimeter |
95% CI: [-6.77, 0.17]