Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

• Assessment of Efficacy

• Knee MRI(Magnetic resonance imaging):

• Assessment of cartilage volume, thickness in target knee
• GAG(glycosaminoglycan) concentration of target knee
• Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee
• Knee radiography:

• Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.
• Knee pain(VAS)

• Assessment changes of pain in target knee.
• K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)

• Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions).
• The questionnaire is self-administered by the patients.
• Used frequency of rescue medicine.
• Biochemical cartilage and bone markers

• Blood and urine sample will be collected all through the morning after a night fasting period since 10 pm the previous day to avoid the variations.
• Assessment of Safety

• Adverse event
• Laboratory assessment
• Vital sign
• 12-lead ECG
• Physical examination
• Enrollment: 76

Inclusion criteria

• A female is eligible if she is of:

• Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
• Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
• Pregnancy test result of negative at screening
• Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.

• ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion)
• Appropriately signed and dated informed consent has been obtained

Exclusion criteria

• Rheumatoid arthritis or inflammatory arthritis.
• Bilateral total knee replacement already treated, or planning for the procedure.
• Knee prosthesis already implanted, or foreseen within the next year.
• Clinically significant hip osteoarthritis.
• Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
• Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
• MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
• Allergic reaction to Clinical trial medication.
• Other clinical trial drugs during the 1 month prior to the screening visit.