Table 2 Exclusion criteria for patients in the open-label study of APS on patients with knee OA

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