Knee OsteoarthritisPhase 3Cingal17-02NCT03390036
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
A Phase 3 study testing Cingal, Monovisc and Triamcinolone Hexacetonide in people with Knee Osteoarthritis, run by Anika Therapeutics, Inc. at 17 sites in 2 countries.
Trial summary
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Cingal, Monovisc and Triamcinolone Hexacetonide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 7 Dec 2017to 30 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Poland10 sites
Zdrowie Osteo-Medic
Bialystok
Szpital Świętego Łukasza S.A.
Bielsko-Biala
NZOZ Medi SPATX
Gliwice
Centrum Medyczne 4M Plus
Krakow
Medical University of Lodz
Lodz
Lubelskie Centrum Diagnostyczne
Świdnik
NOVAMED Jackowiak Krajewski Spółka Jawna
Torun
Centrum Medyczne Amed Warszawa Targówek
Warsaw
ETG Network, Warsaw
Warsaw
ETG Network
Warsaw
Hungary7 sites
Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
Budapest, 1051
Uzsoki Hospital, Department of Traumatology
Budapest, 1145
Jutrix Medical Llc
Budapest, 6000
Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
Budapest
DE KK Ortopediai Klinika
Debrecen
Medidea Bt.
Kiskunfélegyháza
Kastelypark Klinka
Tata
About this study
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
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- Cingal, Monovisc, Triamcinolone Hexacetonide
- Keywords
- Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CingalCombination product
Also called HA + TH
Hyaluronic Acid with Triamcinolone Hexacetonide
MonoviscDevice
Also called HA
Hyaluronic Acid
Triamcinolone HexacetonideDrug
Also called TH
Triamcinolone Hexacetonide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Triamcinolone Hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 39 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 39 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start7 Dec 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laszlo Hangody, MD, Principal investigator, Uzsoki Hospital, Department of Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390036
- Sponsor's protocol ID
- Cingal 17-02
- Acronym
- Cingal17-02
- Status last verified
- May 2023
- First submitted
- 28 Dec 2017
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03390036
- Acronym / sponsor ID
- Cingal17-02 / Cingal 17-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Intra-articular Injection, Hyaluronic Acid, Triamcinolone Hexacetonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 31 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cingal | Experimental | Combination Product: CingalCingal 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 | Active comparator | Device: MonoviscMonovisc 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) | Active comparator | Drug: Triamcinolone HexacetonideTriamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CingalAlso: HA + THHyaluronic Acid with Triamcinolone Hexacetonide | Combination product | Cingal |
| MonoviscAlso: HAHyaluronic Acid | Device | Monovisc |
| Triamcinolone HexacetonideAlso: THTriamcinolone Hexacetonide | Drug | Triamcinolone Hexacetonide (TH) |
Primary outcome
OMERACT-OARSI Responder Rate at 39 Weeks
Time frame: 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.
7 secondary outcomes
Change From Baseline in WOMAC Pain Score at 39 Weeks
Time frame: 39 Weeks
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
Time frame: 39 Weeks
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
Time frame: 39 Weeks
Change From Baseline in Total WOMAC Score at 39 Weeks
Time frame: 39 Weeks
Change From Baseline in Patient Global Assessment at 39 Weeks
Time frame: 39 Weeks
Change From Baseline in Evaluator Global Assessment at 39 Weeks
Time frame: 39 Weeks
The Usage of Rescue Medication (Acetaminophen) at Week 39
Time frame: 39 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laszlo Hangody, MD principal investigator
Uzsoki Hospital, Department of Traumatology
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cingal, Monovisc and Triamcinolone Hexacetonide in people with Knee Osteoarthritis, run by Anika Therapeutics, Inc. at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Poland, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMERACT-OARSI Responder Rate at 39 Weeks (time frame: 39 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.