Efficacy of Subcutaneous Injection of Etanercept for Moderate and Severe Knee Osteoarthritis

Launched by FIRST AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY · Mar 29, 2016

Keywords

ClinConnect Summary

1. Background:

Osteoarthritis (osteoarthritis, OA) is a common joint disease. It is characterized by recurrent joint pain, swelling, increasing of disease status, joint deformity and activity disorders.

The pathogenesis of OA has not been fully understood. It may be associated with a variety of factors, such as: mechanics, biochemistry, genetics, and so on. Its main feature is the imbalance between synthesis and catabolism of articular cartilage cells. The imbalance may refer to cell aging, cell apoptosis, local inflammatory factor in joints as well as stress mechanism and so on.

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Willing and able to give full consent;
• • 2. According with classification of "Clinical Image" of 1986 American college of rheumatology criteria in osteoarthritis of the knee ;
• • 3. Grade II-IV of Kellgren-Lawrence (KL) grading system, revealing synovial inflammation or synovial fluid by combining ultrasound and MRI
• • 4. Knee pain for at least 1 Month and average pain of last week rated as moderate and severe, Pain VAS Score\>4;
• • 5. Fertile women agreed to adopt effective contraceptive measures during the test.
• • Exclusion criteria
• • 1. Allergic to pharmaceutical ingredients;
• • 2. Received Tumor Necrosis Factor inhibitor (TNFI) or other biologics preparation within 3 months;
• • 3. Received physical therapy or articular injection, taking antidepressants or antispasmodic, opioids within 3 months ;
• • 4. Patients with history of knee surgery or upcoming surgery within 10 years;
• • 5. Patients accompanied by other complications or joint disease (such as septic arthritis, osteonecrosis,haemochromatosis, ochronosis, etc.);
• • 6. Patients with active or a history of recurrent infections;
• • 7. Patients existing active tuberculosis (TB) or has a history of active TB;
• • 8. Patients with positive on hepatitis b surface antigen or hepatitis c antibody;
• • 9. Patients with a history of severe lung disease, tumor;
• • 10. Patients with severely abnormal function on liver and kidney (liver enzyme \> = 2 times normal, creatinine \> = normal);
• • 11. Patients with pregnancy, ready for pregnancy or lactation;
• • 12. Patients with other conditions which not suitable for use of Etanercept.