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

NCT03390036 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: Cingal 17-02
• Study Type: interventional
• Target: 526
• Locations: 2 countries
• Sites: 17

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change From Baseline in WOMAC Pain Score at 39 Weeks

  39 Weeks

• Change From Baseline in WOMAC Physical Function Score at 39 Weeks

  39 Weeks

• Change From Baseline in WOMAC Stiffness Score at 39 Weeks

  39 Weeks

• Change From Baseline in Total WOMAC Score at 39 Weeks

  39 Weeks

• Change From Baseline in Patient Global Assessment at 39 Weeks

  39 Weeks

Study Arms (3)

Cingal

EXPERIMENTAL

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

Monovisc

ACTIVE COMPARATOR

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

Triamcinolone Hexacetonide (TH)

ACTIVE COMPARATOR

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

Drug: Triamcinolone Hexacetonide

Interventions

Cingal COMBINATION_PRODUCT

Hyaluronic Acid with Triamcinolone Hexacetonide

Also known as: HA + TH

Cingal

Monovisc DEVICE

Hyaluronic Acid

Also known as: HA

Monovisc

Triamcinolone Hexacetonide DRUG

Triamcinolone Hexacetonide

Also known as: TH

Triamcinolone Hexacetonide (TH)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (17)

Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)

Budapest, 1051, Hungary

Location

Uzsoki Hospital, Department of Traumatology

Budapest, 1145, Hungary

Location

Jutrix Medical Llc

Budapest, 6000, Hungary

Location

Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly

Budapest, Hungary

Location

DE KK Ortopediai Klinika

Debrecen, Hungary

Location

Medidea Bt.

Kiskunfélegyháza, Hungary

Location

Kastelypark Klinka

Tata, Hungary

Location

Zdrowie Osteo-Medic

Bialystok, Poland

Location

Szpital Świętego Łukasza S.A.

Bielsko-Biala, Poland

Location

NZOZ Medi SPATX

Gliwice, Poland

Location

Centrum Medyczne 4M Plus

Krakow, Poland

Location

Medical University of Lodz

Lodz, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

Location

NOVAMED Jackowiak Krajewski Spółka Jawna

Torun, Poland

Location

Centrum Medyczne Amed Warszawa Targówek

Warsaw, Poland

Location

ETG Network, Warsaw

Warsaw, Poland

Location

ETG Network

Warsaw, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

3,6,9,16,19,22-hexaaza-6,19-bis(2-hydroxyethyl)tricyclo(22,2,2,2(11,14))triaconta-1,11,13,24,27,29-hexaene; triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Cingal 17-02, an extension study of Cingal 16-02, did not include a placebo arm, and was an all-active trial.

Results Point of Contact

• Title: Carol Pekar, VP Clinical Affairs
• Organization: Anika

cpekar@anikatherapeutics.com

781-457-9218

Study Officials

• Laszlo Hangody, MD

  Uzsoki Hospital, Department of Traumatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study subjects and the Outcomes Assessor are blinded to the study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: December 7, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (10); HU (7)