Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

Study Overview
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Brief Summary
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Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data

Detailed Description
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Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

Official Title
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Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Combination Product: Cingal
* Device: Monovisc
* Drug: Triamcinolone Hexacetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent. Exclusion Criteria: Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.

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
Interventional Model Description: In the 16-02 study, subjects were randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arm. The 17-02 study is a 39-week follow-up to the 16-02 study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cingal<br>Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection. | Combination Product: Cingal<br>* Hyaluronic Acid with Triamcinolone Hexacetonide<br>* Other names: HA + TH;|
| Active Comparator: Monovisc<br>Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection. | Device: Monovisc<br>* Hyaluronic Acid<br>* Other names: HA;|
| Active Comparator: Triamcinolone Hexacetonide (TH)<br>Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection. | Drug: Triamcinolone Hexacetonide<br>* Triamcinolone Hexacetonide<br>* Other names: TH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OMERACT-OARSI Responder Rate at 39 Weeks | The post treatment Responder Rate at 39 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome. | 39 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in WOMAC Pain Score at 39 Weeks | The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome. | 39 Weeks | 
| Change From Baseline in WOMAC Physical Function Score at 39 Weeks | This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. | 39 Weeks | 
| Change From Baseline in WOMAC Stiffness Score at 39 Weeks | The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness. | 39 Weeks | 
| Change From Baseline in Total WOMAC Score at 39 Weeks | The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score. | 39 Weeks | 
| Change From Baseline in Patient Global Assessment at 39 Weeks | Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today? The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. | 39 Weeks | 
| Change From Baseline in Evaluator Global Assessment at 39 Weeks | Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded Outcomes Assessor, and answers the question Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today? The Evaluator Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. | 39 Weeks | 
| The Usage of Rescue Medication (Acetaminophen) at Week 39 | The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group. | 39 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide