Phase 2
Completed N=80
SI-613 Study for Knee Osteoarthritis
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03209362 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Sep 2021
Primary outcomePrimary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks — -29.9; -27.0 score on a scale — p=0.5453
Summary
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks |
-29.9; -27.0 | 0.5453 |
| SECONDARY Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26 |
-40.4; -36.9; -41.7; -38.4 | 0.5386 |
| SECONDARY Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26 |
-39.2; -36.3; -38.5; -36.7 | 0.6347 |
| SECONDARY Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26 |
-38.2; -37.3; -41.4; -35.7 | 0.8819 |
| SECONDARY Change From Baseline in WOMAC Total Score at Weeks 12 and 26 |
-39.4; -36.4; -39.4; -36.9 | 0.6217 |
Eligibility Criteria
Inclusion Criteria
- Provides their written informed consent.
- Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
- Is willing to switch to using acetaminophen as a rescue medication
Exclusion Criteria
- Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
- Secondary OA
- Is a female subject who is pregnant or lactating.
- Is currently hospitalized or has a planned hospitalization during the life of the study.
Data sourced from ClinicalTrials.gov (NCT03209362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.