Trial Outcomes & Findings for SI-613 Study for Knee Osteoarthritis (NCT NCT03209362)
NCT ID: NCT03209362
Last Updated: 2021-11-04
Results Overview
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline over 12 weeks
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
SI-613
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
SI-613
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
SI-613 Study for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 8.32 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.62 Kilograms / meter square
STANDARD_DEVIATION 4.251 • n=5 Participants
|
30.64 Kilograms / meter square
STANDARD_DEVIATION 4.669 • n=7 Participants
|
30.63 Kilograms / meter square
STANDARD_DEVIATION 4.442 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline over 12 weeksObserved VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
Outcome measures
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
|
-29.9 score on a scale
Interval -36.7 to -23.1
|
-27.0 score on a scale
Interval -33.6 to -20.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 26Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Outcome measures
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Change at Week 12
|
-40.4 score on a scale
Interval -48.5 to -32.3
|
-36.9 score on a scale
Interval -44.8 to -28.9
|
|
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Change at Week 26
|
-41.7 score on a scale
Interval -50.2 to -33.1
|
-38.4 score on a scale
Interval -46.7 to -30.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 26Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Outcome measures
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Change at Week 12
|
-39.2 score on a scale
Interval -47.9 to -30.6
|
-36.3 score on a scale
Interval -44.8 to -27.8
|
|
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Change at Week 26
|
-38.5 score on a scale
Interval -47.4 to -29.5
|
-36.7 score on a scale
Interval -45.5 to -28.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 26Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Outcome measures
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Change at Week 12
|
-38.2 score on a scale
Interval -47.0 to -29.4
|
-37.3 score on a scale
Interval -45.9 to -28.7
|
|
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Change at Week 26
|
-41.4 score on a scale
Interval -50.4 to -32.3
|
-35.7 score on a scale
Interval -44.6 to -26.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12 and 26WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Outcome measures
| Measure |
SI-613
n=39 Participants
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 Participants
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
Change at Week 12
|
-39.4 score on a scale
Interval -47.9 to -30.9
|
-36.4 score on a scale
Interval -44.8 to -28.1
|
|
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
Change at Week 26
|
-39.4 score on a scale
Interval -48.2 to -30.6
|
-36.9 score on a scale
Interval -45.5 to -28.3
|
Adverse Events
SI-613
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SI-613
n=39 participants at risk
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 participants at risk
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Baseline up to Week 26
|
0.00%
0/41 • Baseline up to Week 26
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
2.6%
1/39 • Baseline up to Week 26
|
0.00%
0/41 • Baseline up to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/39 • Baseline up to Week 26
|
2.4%
1/41 • Baseline up to Week 26
|
Other adverse events
| Measure |
SI-613
n=39 participants at risk
The participants received repeated intra-articular knee injection of 30 mg SI-613 (1 injection every 4 weeks, total of 3 injections).
|
Placebo
n=41 participants at risk
The participants received repeated intra-articular knee injection of Placebo (1 injection every 4 weeks, total of 3 injections).
|
|---|---|---|
|
General disorders
Injection site joint pain
|
7.7%
3/39 • Baseline up to Week 26
|
4.9%
2/41 • Baseline up to Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.8%
5/39 • Baseline up to Week 26
|
4.9%
2/41 • Baseline up to Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER