Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03390036 | Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up | PHASE3 | COMPLETED | 526 | — | — | Dec 7, 2017 | Jul 30, 2018 | May 31, 2023 | 17 | Hungary, Poland |
| NCT03191903 | Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide | PHASE3 | COMPLETED | 576 | — | — | May 25, 2017 | Apr 23, 2018 | Feb 24, 2022 | 19 | Hungary, Poland |
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.
The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the TH group. 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Cingal | COMBINATION_PRODUCT | Hyaluronic Acid with Triamcinolone Hexacetonide |
| Monovisc | DEVICE | Hyaluronic Acid |
| Triamcinolone Hexacetonide | DRUG | Triamcinolone Hexacetonide |
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. ...