Compliance behavior Study Protocol
Item
willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Age
Item
male or female >=40 years of age
boolean
C0001779 (UMLS CUI [1])
Osteoarthritis, Knee Symptoms Associated with
Item
has symptoms associated with oa of the index knee for at least 6 months prior to screening
boolean
C0409959 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
Degenerative polyarthritis | American College of Rheumatology Improvement Criteria Fulfill
Item
currently meets american college of rheumatology (acr) criteria (clinical and radiological) for oa
boolean
C0029408 (UMLS CUI [1])
C3273747 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Knee Radiographic imaging procedure | Kellgren-Lawrence score
Item
kellgren-lawrence (k-l) grade 2 or 3 in the index knee per screening x-ray
boolean
C0022742 (UMLS CUI [1,1])
C1962945 (UMLS CUI [1,2])
C3177117 (UMLS CUI [2])
Knee pain Duration
Item
index knee pain for > 15 days over the last month
boolean
C0231749 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Mean score Qualifying | Pain score 24 hour Average | Numeric Rating Scale
Item
qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
boolean
C3533236 (UMLS CUI [1,1])
C1514624 (UMLS CUI [1,2])
C0582148 (UMLS CUI [2,1])
C0439584 (UMLS CUI [2,2])
C1510992 (UMLS CUI [2,3])
C4050142 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) ≤ 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Abstinence Pharmaceutical Preparations Restricted
Item
willingness to abstain from use of restricted medications
boolean
C3843422 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
medical condition Interferes with Assessment Knee pain | Osteoarthritis of hip Ipsilateral | Gout | Low Back Pain Radicular pain | Hip pain
Item
any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iipsilateral hip oa, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
boolean
C1699700 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0231749 (UMLS CUI [1,4])
C0029410 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0024031 (UMLS CUI [4,1])
C0278147 (UMLS CUI [4,2])
C0019559 (UMLS CUI [5])
Fibromyalgia | Reiter Syndrome | Rheumatoid Arthritis | Arthritis, Psoriatic | Ankylosing spondylitis | Arthritis Associated with Inflammatory Bowel Diseases
Item
fibromyalgia, reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
boolean
C0016053 (UMLS CUI [1])
C0035012 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C0038013 (UMLS CUI [5])
C0003864 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C0021390 (UMLS CUI [6,3])
Communicable Diseases Knee
Item
history of infection in the index knee
boolean
C0009450 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
Signs and Symptoms knee; infection | Signs and Symptoms Calcium pyrophosphate deposition disease Knee
Item
clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of screening
boolean
C0037088 (UMLS CUI [1,1])
C1400580 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0553730 (UMLS CUI [2,2])
C0022742 (UMLS CUI [2,3])
Joint Instability
Item
unstable joint within 12 months of screening
boolean
C0022410 (UMLS CUI [1])
Intraarticular Corticosteroid Joint Any | Investigational New Drugs | drugs marketed
Item
ia corticosteroid (investigational or marketed) in any joint within 3 months of screening
boolean
C4054701 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C0680164 (UMLS CUI [3])
Knee Intra-Articular Injections Hyaluronic Acid | Investigational New Drugs | drugs marketed
Item
ia hyaluronic acid (investigational or marketed) in the index knee within 6 months of screening
boolean
C0022742 (UMLS CUI [1,1])
C0021488 (UMLS CUI [1,2])
C0020196 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C0680164 (UMLS CUI [3])
Intramuscular steroid therapy | Adrenal Cortex Hormones | Investigational New Drugs | drugs marketed
Item
intramuscular (im) or oral corticosteroids (investigational or marketed) within 1 month of screening
boolean
C0585373 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0680164 (UMLS CUI [4])
Investigational New Drugs Intra-articular Other | Biological Factors Intra-articular Other
Item
any other ia investigational drug/biologic within 6 months of screening
boolean
C0013230 (UMLS CUI [1,1])
C0442108 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0005515 (UMLS CUI [2,1])
C0442108 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Triamcinolone Acetonide Use Previous
Item
prior use of fx006
boolean
C0040866 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Childbearing Potential | Contraceptive methods Not used | Pregnancy | Breast Feeding
Item
women of child-bearing potential not using effective contraception or who are pregnant or nursing
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0445107 (UMLS CUI [2,2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])