|
Signed Informed Consent
|
X
| | | |
|
Inclusion/Exclusion Reviewed
|
X
|
X
|
X
| |
|
Medical/Surgical/Medication History
|
X
| | | |
|
Physical Examination
|
X
| | | |
|
Vital Signs
|
X
|
X
|
X
|
X
|
|
Heighta, Weight, BMI
|
X
| | |
X
|
|
Clinical Assessment for Knee Pain & Swelling
|
X
|
X
|
X
|
X
|
|
Knee Flexion Range of Motion
| |
X
|
X
|
X
|
|
X-ray examination
|
X
| | | |
|
WOMAC Score
|
X
|
X
|
X
|
X
|
|
VAS Scale
|
X
|
X
|
X
|
X
|
|
LFI Score
|
X
|
X
|
X
|
X
|
|
Clinical Laboratory Tests (hematology, chemistry, urinalysis)
|
X
| | |
X
|
|
Urine Pregnancy Test (if applicable)
|
X
| |
X
|
X
|
|
Serum biomarker analysis-COMP
| |
X
| |
X
|
|
Randomization Number Assigned
| |
X
| | |
|
Investigational Product Administration
| |
X
| | |
|
Dispense Subject Diary
| |
X
|
X
| |
|
Collect/Review Subject Diary
| | |
X
|
X
|
|
Provide Directions for Concomitant Medication and Rescue Medication Use
|
X
|
X
|
X
| |
|
Dispense New Investigational Product
| |
X
|
X
| |
|
Review Product Accountability
| | |
X
|
X
|
|
Assess use of Concomitant Medications
| |
X
|
X
|
X
|
|
Adverse Events Assessed
| |
X
|
X
|
X
|
|
Procedures Confined to Protocol 003348
| | | | |
|
Synovial fluid biomarker—MMP-3 and IL-6
| |
X
| |
X
|
|
Serum biomarker analysis—CRP
| |
X
| |
X
|
