Table 2.
Exclusion criteria for patients in the open-label study of APS on patients with knee OA
| Exclusion Criteria |
|---|
| Disease Related Criteria |
| On day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling) |
| Diagnosed with rheumatoid arthritis (RA), Reiter’s syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis) |
| Arthritis of metabolic origin |
| Ipsilateral hip OA |
| Untreated traumatic injury of knee |
| Limited daily activity for reasons other than OA |
| Presence of surgical hardware or other foreign body in the knee |
| Prior or concomitant OA treatment-related criteria |
| Arthroscopy or open surgery in knee within 12 months prior to screening |
| Intra-articular steroid injections in any joint within 3 months prior to screening |
| Intra-articular HA in any joint within 6 months prior to screening |
| Other intra-articular therapy in any joint within 3 months prior to screening |
| Taking systemic steroids within 2 weeks prior to screening |
| Planned/anticipated surgery of the knee during the study period |
| Patient-related criteria: |
| Any clinically significant results at screening (values or findings outside of normal ranges that were deemed clinically significant by the investigator) |
| Active or history of malignancy other than non-melanoma skin cancer |
| Any serious, non-malignant, significant, acute, or chronic medical condition (e.g., diabetes, cardiopathy) or active psychiatric illness that, in the investigator’s opinion, could have compromised patient safety, limited the patient’s ability to complete the study, and/or compromised the objectives of the study |
| Skin breakdown at the knee where the injection was planned to take place |
| Pregnant or nursing mothers, or women likely to conceive a child and unwilling to use a reliable form of birth control for the duration of the study |
| History of drug or alcohol dependence, and/or positive screening results from urine drug and alcohol tests |
| Used any investigational drug or device within 30 days prior to screening, or 5 half-lives, whichever is longer |
| Used any investigational biologic within 60 days prior to screening |