Trial Outcomes & Findings for Euflexxa for the Treatment of Osteoarthritis (NCT NCT03459365)

Results Overview

The concentration of hyaluronate in the synovial fluid will be measured using Fluorophore-assisted carbohydrate electrophoresis. The difference between the mean concentration at baseline and 6 months is reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2024-09-04

Participant Flow

There were 30 knees (from 24 patients) recruited (some patients treated on both knees). 7 knees withdrew from the study. 8 knees had dry taps. This left 15 knees from 11 patients with adequate baseline aspirates. One of the 1-month aspirates was too bloody to process, leaving 14 knees from 10 patients with adequate baseline and 1 month samples. 3 knees had dry taps at 6 months, leaving 11 knees from 10 patients with adequate baseline, 1 month, and 6 month aspirates for data analysis.

Unit of analysis: Knees

Participant milestones

Participant milestones
Measure	Euflexxa Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Overall Study STARTED	24 30
Overall Study COMPLETED	10 11
Overall Study NOT COMPLETED	14 19

Reasons for withdrawal

Reasons for withdrawal
Measure	Euflexxa Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Euflexxa n=10 Participants Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Age, Continuous	52 years STANDARD_DEVIATION 11 • n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=10 Participants
Body mass index, continuous	30 kg/m^2 STANDARD_DEVIATION 7 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: 11 knees from 10 patients

The concentration of hyaluronate in the synovial fluid will be measured using Fluorophore-assisted carbohydrate electrophoresis. The difference between the mean concentration at baseline and 6 months is reported.

Outcome measures

Outcome measures
Measure	Euflexxa n=11 knees Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Change in Hyaluronate Concentration	0.29568 mg/ml Standard Deviation 1.65476

SECONDARY outcome

Timeframe: Baseline to 6 months

The levels of TSG-6 in the synovial fluid will be measured using Enzyme-linked immunosorbent assay. The difference in mean concentration between baseline and 6 months post injection is reported.

Outcome measures

Outcome measures
Measure	Euflexxa n=11 knees Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Changes in Tumor Necrosis Factor-stimulated Gene 6 (TSG-6)	3450 ng/ml Standard Deviation 5831

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: 11 knees (10 patients)

Change in VAS (visual analogue scale) pain score compared to baseline in the study cohort. VAS is a measure of pain with 0 being best and 10 being worst pain on a 10 cm scale (100 mm).

Outcome measures

Outcome measures
Measure	Euflexxa n=11 knees Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
VAS Pain Score Improvement	40 mm Standard Deviation 13

Adverse Events

Euflexxa

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Euflexxa n=10 participants at risk Two sets of Euflexxa injection at 0 and 6 months. Each set consists of 3 injections 1 week apart. Euflexxa: Aspirations performed before each injection and at six weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	10.0% 1/10 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Carlos Higuera

Cleveland Clinic

Phone: 954 659-5430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place