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

Knee Osteoarthritis Clinical Trial

— Cingal17-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390036
• Other study ID #: Cingal 17-02
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2023
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• Cingal
Hyaluronic Acid with Triamcinolone Hexacetonide

Device:
• Monovisc
Hyaluronic Acid

Drug:
• Triamcinolone Hexacetonide
Triamcinolone Hexacetonide

Locations

Country	Name	City	State
Hungary	Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)	Budapest
Hungary	Jutrix Medical Llc	Budapest
Hungary	Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly	Budapest
Hungary	Uzsoki Hospital, Department of Traumatology	Budapest
Hungary	DE KK Ortopediai Klinika	Debrecen
Hungary	Medidea Bt.	Kiskunfelegyhaza
Hungary	Kastelypark Klinka	Tata
Poland	Zdrowie Osteo-Medic	Bialystok
Poland	Szpital Swietego Lukasza S.A.	Bielsko-Biala
Poland	NZOZ Medi SPATX	GLIwice
Poland	Centrum Medyczne 4M Plus	Kraków
Poland	Medical University of Lodz	Lódz
Poland	Lubelskie Centrum Diagnostyczne	Swidnik,
Poland	NOVAMED Jackowiak Krajewski Spólka Jawna	Torun
Poland	Centrum Medyczne Amed Warszawa Targówek	Warsaw
Poland	ETG Network	Warsaw
Poland	ETG Network, Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Countries where clinical trial is conducted

Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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