A Phase 3 interventional study of Cingal and Monovisc in Knee Osteoarthritis, sponsored by Anika Therapeutics, Inc.. Completed at 17 sites in 2 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Anika Therapeutics, Inc. · Phase 3, Interventional, and Treatment
Among 77 studies in Osteoarthritis, Knee with a site in Poland — 12 open to participants now, 13 under way, 2 of them phase 3. Osteoarthritis, Knee · Poland.
Among the 77 studies in Osteoarthritis, Knee with a site in Poland, this one is the 15th largest by enrollment of the 71 interventional ones, is one of 5 that started in 2017, is one of 16 in phase 3, and was the 17th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 526 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →12 of the 77 studies in Osteoarthritis, Knee with a site in Poland are open now, in 12 countries. Each count lists the studies.
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 40 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →77 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 5 started in 2017.
Median enrollment 120 across the 71 interventional studies, 131 across the 6 observational. Of the 57 that completed or were terminated, 21 (37%) have results posted.
41 of 77 have an industry lead sponsor. The 10 most frequent:
Anika Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Anika Therapeutics, Inc. has 5 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
3 of the studies in Osteoarthritis, Knee with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07449442Poznan University of Medical SciencesSII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty | 2026-11-30 |
| NCT07813078University of RzeszowAnti-Gravity Treadmill Gait Training for Knee Osteoarthritis | 2026-12-31 |
| NCT07677215Poznan University of Medical SciencesACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty | 2027-09-01 |
Among the 77 studies in Osteoarthritis, Knee with a site in Poland, from their registry updates:
Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Drug: Triamcinolone Hexacetonide
Hyaluronic Acid with Triamcinolone Hexacetonide
Also known as: HA + TH
Hyaluronic Acid
Also known as: HA
Triamcinolone Hexacetonide
Also known as: TH
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.
Time frame: 39 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 39 Weeks
Subjects enrolled in Cingal 16-02 were given the option to enroll in Cingal 17-02 for a 39-week follow-up. 233 subjects in the Cingal arm (95%), 230 subjects in the Monovisc arm (93%), and 63 subjects in the Triamcinolone Hexacetonide arm (90%) elected to enroll in the extension study.
| Milestone | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Started | 233 | 230 | 63 |
| Completed | 231 | 230 | 63 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
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.
| Percentage of subjects | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| OMERACT-OARSI Responder Rate at 39 Weeks | 91.2 | 92.4 | 93.2 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline in WOMAC Pain 39 Weeks | -46.3 ± 20.2 | -47.2 ± 18.6 | -43.6 ± 21.4 |
| Baseline WOMAC Pain in mm | 63.3 ± 11.0 | 63.3 ± 11.3 | 63.8 ± 11.3 |
| 39 Week WOMAC Pain in mm | 17.0 ± 19.3 | 16.0 ± 18.6 | 20.1 ± 21.1 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline WOMAC Function 39 Weeks | -42.5 ± 22.4 | -43.5 ± 20.7 | -41.1 ± 22.5 |
| Baseline WOMAC Function | 60.8 ± 15.2 | 60.8 ± 15.8 | 61.8 ± 15.7 |
| 39 Week WOMAC Function | 18.4 ± 19.8 | 17.3 ± 18.6 | 20.7 ± 21.3 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline in WOMAC Stiffness 39 Weeks | -39.8 ± 24.4 | -42.0 ± 22.4 | -38.0 ± 24.9 |
| Baseline WOMAC Stiffness in mm | 57.7 ± 19.3 | 59.2 ± 18.1 | 57.9 ± 17.6 |
| 39 Week WOMAC Stiffness in mm | 17.9 ± 20.0 | 17.2 ± 18.6 | 19.9 ± 21.9 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline in Total WOMAC 39 Weeks | -128.4 ± 63.1 | -132.6 ± 56.6 | -122.7 ± 62.2 |
| Baseline Total WOMAC in mm | 181.8 ± 40.6 | 183.4 ± 39.4 | 183.5 ± 38.4 |
| 39 Week Total WOMAC in mm | 53.4 ± 58.1 | 50.8 ± 54.6 | 60.8 ± 62.5 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline in Patient Global 39 weeks | -38.6 ± 25.4 | -38.2 ± 22.8 | -36.7 ± 28.0 |
| Baseline Patient Global in mm | 57.0 ± 18.9 | 56.0 ± 18.6 | 58.2 ± 20.3 |
| 39 Week Patient Global in mm | 18.4 ± 19.8 | 17.8 ± 19.4 | 21.5 ± 22.1 |
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.
| Millimeters (mm) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| Change from Baseline in Evaluator Global 39 eeks | -37.1 ± 21.3 | -37.7 ± 19.9 | -39.1 ± 22.1 |
| Baseline Evaluator Global in mm | 52.9 ± 17.2 | 52.3 ± 17.7 | 56.6 ± 18.1 |
| 39 Week Evaluator Global in mm | 15.8 ± 16.5 | 14.6 ± 16.5 | 17.4 ± 15.6 |
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.
| Number of pills | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| The Usage of Rescue Medication (Acetaminophen) at Week 39 | 7.9 ± 39.5 | 6.0 ± 18.7 | 6.9 ± 22.8 |
Collected over Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.. Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cingal | 0/233 (0%) | 0/233 (0%) | 20/233 (8.6%) |
| Monovisc | 0/230 (0%) | 0/230 (0%) | 19/230 (8.3%) |
| Triamcinolone Hexacetonide (TH) | 0/63 (0%) | 0/63 (0%) | 6/63 (9.5%) |
| Event | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) |
|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/233 | 4/230 | 0/63 |
| Viral upper respiratory tract infectionInfections and infestations | 2/233 | 2/230 | 2/63 |
| Abdominal painGastrointestinal disorders | 0/233 | 0/230 | 2/63 |
| HeadacheNervous system disorders | 7/233 | 6/230 | 0/63 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/233 | 4/230 | 0/63 |
| Spinal painMusculoskeletal and connective tissue disorders | 1/233 | 3/230 | 1/63 |
| ArrythmiaCardiac disorders | 1/233 | 0/230 | 1/63 |
ITT Population
| Age, Continuous(years) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) | Total |
|---|---|---|---|---|
| Mean | 57.8 ± 8.8 | 57.7 ± 8.9 | 59.2 ± 8.4 | 57.9 ± 8.8 |
| Sex: Female, Male(Participants) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) | Total |
|---|---|---|---|---|
| Female | 165 | 152 | 44 | 361 |
| Male | 68 | 78 | 19 | 165 |
| Race (NIH/OMB)(Participants) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 233 | 230 | 63 | 526 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Baseline WOMAC Pain in Index Knee(millimeters (mm)) | Cingal | Monovisc | Triamcinolone Hexacetonide (TH) | Total |
|---|---|---|---|---|
| Mean | 63.5 ± 11.1 | 63.7 ± 11.4 | 64.6 ± 10.9 | 63.7 ± 11.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to make individual participant data available to other researchers
Ran from Dec 2017 to primary completion in Jul 2018, 7 months.
Results were first posted in May 2023, 4 years 10 months after primary completion.
Of 65 industry-sponsored phase 3 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 27. This study's 7 months is below that.
Counting every sponsor, half of 100 studies reached it within 21 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Anika Therapeutics, Inc.