Advertisement
Table 1 Inclusion criteria for patients in the open-label study of APS on patients with OA
| Inclusion Criteria |
|---|
| Male or female ≥40 years |
| Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions |
| A standing radiograph of the knee showing a Kellgren grade of 2 or 3 (within 6 months prior to screening or at screening) |
| Frequency of knee pain on most days (>15 days) over the last month |
| Diagnosis of unilateral knee OA according to the American College of Rheumatology (ACR) criteria (clinical and radiological categories) based on an x-ray performed within 6 months prior to screening |
| Body mass index (BMI) ≤40 kg/m2 |
| On the WOMAC LK 3.1 questionnaire, the mean total score of the 5 pain subscale items together must be ≥ 2.0 at screening and at baseline (Day 1 pre-injection) |
| Failed at least 1 prior conservative OA therapy (physiotherapy and/or simple analgesics) |
| Signed an IEC-approved ICF |
| Willingness to abstain from the use of topical pain therapies (e.g., NSAIDs, capsaicin, lidocaine patches, heat patches), intra-articular corticosteroids, and viscosupplementation during the study |
| Willingness to abstain from systemic pain medications, except for rescue medication (acetaminophen, maximum daily dose ≤ 4 g); also, to abstain from rescue medication for at least 48 h prior to post-screening study visits |
