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Table 1 Protocol Schedule and Activities
| Procedures common to both protocols | Screening (Visit 1) | Study period | ||
|---|---|---|---|---|
| Day 1 (Baseline Visit 2) | Days 7, 30, 60, 90, 120, 150 (Visits 3, 4, 5, 6, 7, 8) | Day 180 (Visit 9) | ||
| 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 | ||
