SI-613 Study for Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Combination Product: SI-613
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI-613<br> | Combination Product: SI-613<br>* SI-613 will be repeated intra-articularly administered.<br>|
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* Placebo will be repeated intra-articularly administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks | 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. | Baseline over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26 | Observed 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. | Baseline, Weeks 12 and 26 | 
| Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26 | Observed 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. | Baseline, Weeks 12 and 26 | 
| Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26 | Observed 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. | Baseline, Weeks 12 and 26 | 
| Change From Baseline in WOMAC Total Score at Weeks 12 and 26 | WOMAC 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. | Baseline, Weeks 12 and 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Osteoarthritis, Intra-articular injection