Hymovis™ Versus Placebo in Knee Osteoarthritis

Study Overview
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Brief Summary
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Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.

Official Title
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A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Hymovis Intra-articular Injection
* Procedure: Phosphate Buffered Saline Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle: Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3 Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study Exclusion Criteria: Clinically significant apparent large effusion of the target knee; Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator; Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease Medical history of anaphylactic reactions History of septic arthritis in any joint Females who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hymovis Viscoelastic Hydrogel<br>Intra-articular Injection | Device: Hymovis Intra-articular Injection<br>* Hymovis Intra-articular injection<br>* Other names: Hyaluronate;|
| Placebo Comparator: Placebo<br>Phosphate Buffered Saline Intra-articular Injection | Procedure: Phosphate Buffered Saline Injection<br>* Placebo Intra-articular injection<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score | WOMAC A Pain sub-score | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analysis | Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | 26 weeks | 
| WOMAC Function | WOMAC C Function sub-score | 26 Weeks | 
| Visual Analog Scale (VAS) WOMAC Pain | Question A1 of WOMAC Pain sub-score | 26 Weeks | 
| WOMAC Global Score |  | 26 Weeks | 
| WOMAC Stiffness sub-score | WOMAC C stiffness sub-score | 26 Weeks | 
| Rescue Medication Usage Pill Count, Failure Outcome |  | 26 Weeks | 
| Patient Global Analysis |  | 26 Weeks | 
| Clinician Responder Analysis |  | 26 Weeks | 
| SF Health Outcome |  | 26 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Hyaluronan, Hyaluronic Acid, Viscoelastic, Hydrogel