Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
526
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
Budapest, Hungary
Uzsoki Hospital, Department of Traumatology
Budapest, Hungary
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.
Time frame: 39 weeks
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.
Time frame: 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.
Time frame: 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.
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Jutrix Medical Llc
Budapest, Hungary
Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
Budapest, Hungary
DE KK Ortopediai Klinika
Debrecen, Hungary
Medidea Bt.
Kiskunfélegyháza, Hungary
Kastelypark Klinka
Tata, Hungary
Zdrowie Osteo-Medic
Bialystok, Poland
Szpital Świętego Łukasza S.A.
Bielsko-Biala, Poland
NZOZ Medi SPATX
Gliwice, Poland
...and 7 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 39 Weeks