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Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up (Cingal17-02)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cingal
Monovisc
Triamcinolone Hexacetonide
Sponsored by
Anika Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
  • Uzsoki Hospital, Department of Traumatology
  • Jutrix Medical Llc
  • Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
  • DE KK Ortopediai Klinika
  • Medidea Bt.
  • Kastelypark Klinka
  • Zdrowie Osteo-Medic
  • Szpital Świętego Łukasza S.A.
  • NZOZ Medi SPATX
  • Centrum Medyczne 4M Plus
  • NOVAMED Jackowiak Krajewski Spółka Jawna
  • Centrum Medyczne Amed Warszawa Targówek
  • ETG Network, Warsaw
  • ETG Network
  • Medical University of Lodz
  • Lubelskie Centrum Diagnostyczne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Cingal

Monovisc

Triamcinolone Hexacetonide (TH)

Arm Description

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.

Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.

Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 28, 2017
Last Updated
May 30, 2023
Sponsor
Anika Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03390036
Brief Title
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anika Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Study subjects and the Outcomes Assessor are blinded to the study treatment.
Allocation
Randomized
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cingal
Arm Type
Experimental
Arm Description
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.
Arm Title
Monovisc
Arm Type
Active Comparator
Arm Description
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Arm Title
Triamcinolone Hexacetonide (TH)
Arm Type
Active Comparator
Arm Description
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Intervention Type
Combination Product
Intervention Name(s)
Cingal
Other Intervention Name(s)
HA + TH
Intervention Description
Hyaluronic Acid with Triamcinolone Hexacetonide
Intervention Type
Device
Intervention Name(s)
Monovisc
Other Intervention Name(s)
HA
Intervention Description
Hyaluronic Acid
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Hexacetonide
Other Intervention Name(s)
TH
Intervention Description
Triamcinolone Hexacetonide
Primary Outcome Measure Information:
Title
OMERACT-OARSI Responder Rate at 39 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC Pain Score at 39 Weeks
Description
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
Title
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
Description
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
Title
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
Description
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.
Time Frame
39 Weeks
Title
Change From Baseline in Total WOMAC Score at 39 Weeks
Description
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
Title
Change From Baseline in Patient Global Assessment at 39 Weeks
Description
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
Title
Change From Baseline in Evaluator Global Assessment at 39 Weeks
Description
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
Title
The Usage of Rescue Medication (Acetaminophen) at Week 39
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laszlo Hangody, MD
Organizational Affiliation
Uzsoki Hospital, Department of Traumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
Uzsoki Hospital, Department of Traumatology
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jutrix Medical Llc
City
Budapest
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
City
Budapest
Country
Hungary
Facility Name
DE KK Ortopediai Klinika
City
Debrecen
Country
Hungary
Facility Name
Medidea Bt.
City
Kiskunfelegyhaza
Country
Hungary
Facility Name
Kastelypark Klinka
City
Tata
Country
Hungary
Facility Name
Zdrowie Osteo-Medic
City
Białystok
Country
Poland
Facility Name
Szpital Świętego Łukasza S.A.
City
Bielsko-Biała
Country
Poland
Facility Name
NZOZ Medi SPATX
City
GLIwice
Country
Poland
Facility Name
Centrum Medyczne 4M Plus
City
Kraków
Country
Poland
Facility Name
NOVAMED Jackowiak Krajewski Spółka Jawna
City
Toruń
Country
Poland
Facility Name
Centrum Medyczne Amed Warszawa Targówek
City
Warsaw
Country
Poland
Facility Name
ETG Network, Warsaw
City
Warsaw
Country
Poland
Facility Name
ETG Network
City
Warsaw
Country
Poland
Facility Name
Medical University of Lodz
City
Łódź
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Świdnik,
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers

Learn more about this trial

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

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