Cingal Study for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Device: Hyaluronic Acid and TH (Cingal®)
Device: Saline
Device: Hyaluronic Acid (Monovisc®)

Registration Number: NCT01891396

Lead Sponsor: Anika Therapeutics, Inc.

Brief Summary: The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Detailed Description: This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 368

Inclusion Criteria

Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

Exclusion Criteria

Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic Acid and TH (Cingal®)	Hyaluronic Acid and TH (Cingal®)	Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe
Saline	Saline	Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe
Hyaluronic Acid (Monovisc®)	Hyaluronic Acid (Monovisc®)	Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)	12 Weeks	The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)	12 Weeks	The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.

Secondary Outcome Measures

Name	Time	Method
OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)	12 Weeks	The post treatment Responder Rate at 12 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)	3 Weeks	The change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)	26 Weeks	Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)	3 Weeks	Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)	3 Weeks	Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (PP population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.
Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)	3 Week	Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the 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 visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)	26 Weeks	Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group. The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)	26 Weeks	Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated 100mm visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
Evaluator Global Assessment Comparing Cingal® to Saline (PP)	26 Weeks	Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the 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 visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Evaluator Global Assessment Comparing Cingal® to Saline (ITT)	26 Weeks	Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the 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 visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).	1 Week	Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the 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 visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)	3 Week	Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the 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 visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)	3 Weeks	Mean change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)	12 Weeks	The post treatment Responder Rate comparing Cingal® and Saline at 12 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). 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.
Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)	26 Weeks	Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.

Trial Locations

Locations (27): Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"
🇧🇬
Sofia, Bulgaria
Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"
🇧🇬
Plovdiv, Bulgaria
Consultative Outpatients' Medical Office for Rheumatologic Diseases
🇧🇬
Sofia, Bulgaria
Department of Orthopaedics Traumatology - Tokuda Hospital Sofia
🇧🇬
Sofia, Bulgaria
Red Deer Regional Hospital Center
🇨🇦
Red Deer, Alberta, Canada
Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital
🇧🇬
Sofia, Bulgaria
Deakon Medicine Professional Corporation
🇨🇦
Oakville, Ontario, Canada
Sports Medicine Specialists
🇨🇦
Toronto, Ontario, Canada
QEII Health Sciences
🇨🇦
Halifax, Canada
Revmacentrum MUDr. Moster, s.r.o.
🇨🇿
Brno, Czechia
Faculty Hospital Plzen
🇨🇿
Plzen, Czechia
Institute of Rheumatology
🇨🇿
Prague, Czechia
Thomayer Hospital Rheumatology Department
🇨🇿
Prague, Czechia
Medical Plus s.r.o.
🇨🇿
Uherske Hradiste, Czechia
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic
🇭🇺
Budapest, Hungary
Semmelweis Egyetem Orthopaedic Clinic
🇭🇺
Budapest, Hungary
Uzsoki Hospital, Department of Traumatology
🇭🇺
Budapest, Hungary
Petz Aladar County Teachin Hospital, Traumatology, Orthopaedics and Hand Surgery Centre
🇭🇺
Gyor, Hungary
Jutrix Medical LLC
🇭🇺
Kecskemet, Hungary
G&V Pharma-Med Bt.
🇭🇺
Mako, Hungary
Medidea Bt.
🇭🇺
Kiskunfelegyhaza, Hungary
NZOZ Medi SPATX
🇵🇱
Gliwice, Poland
Osteo-Medic s.c.
🇵🇱
Bialystok, Poland
ARTIMED Niepubliczny Zakład Opieki Zdrowotnej
🇵🇱
Kielce, Poland
CenterMed Krakow Sp. x. o.o.
🇵🇱
Krakow, Poland
Radlinski Regional Centre of Orthopeadics and Rehabilitation of Locomotor Organs
🇵🇱
Lodz, Poland
Wojewódzki Zespół Reumatologiczny im. Dr Jadwigi Titz-Kosko
🇵🇱
Sopot, Poland