Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI

Inclusion Criteria

• Individuals of either sex, aged 40 years and more
• Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion
• OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
• Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray
• VAS of pain while walking ≥ 40 mm

Exclusion Criteria

• Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose or NSAIDs
• Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
• Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years
• Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
• Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
• Class IV functional capacity using the American Rheumatism Association criteria
• Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit
• History of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure
• High risk of CV events, according to the AHA assessment of CV risk tables
• History of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required
• Have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
• Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, tramadol, codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the 12 weeks preceding inclusion
• Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion
• Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline;
• Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
• Receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
• Subjects who are receiving NSAID and do not want to stop during the study
• If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study
• Have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit
• Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg)
• Have received chondrocyte transplants in any lower extremity joint
• Use oral or topical COXIBs, calcitonin or immunosuppressive drugs