Osteoarthritis Of Knee Clinical Trial
— ESIETNKOAOfficial title:
Efficacy of Subcutaneous Injection of Etanercept for Moderate and Severe Knee Osteoarthritis
Primary aim: evaluate efficacy of subcutaneous injection of etanercept for moderate and
severe knee osteoarthritis.
Second aim: investigate the potentiality of serum cytokines (TNF-α, L1-α, IL1-β, MMP1,
MMP13) to predict the response of subcutaneous injection of etanercept for moderate and
severe knee osteoarthritis.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 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, osteochondritis desiccans, osteonecrosis,haemochromatosis, ochronosis, etc.); 6. Patients with active or a history of recurrent infections; 7. Patients existing active 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Harbin Medical University | Shanghai Baiying Medical Technology Co., Ltd. |
China,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse event | Type and frequency of adverse event | 2 weeks, 4 weeks, 8 weeks and 12 weeks | Yes |
Primary | Pain VAS score(Pain Visual Analogue Scale/Score) | Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy | baseline to 8 weeks and 12 weeks | No |
Primary | KOOS score(The Knee injury and Osteoarthritis Score) | Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy | baseline to 8 weeks and 12 weeks | No |
Secondary | 30s-CST score(30 seconds Sit/chair Test) | Changes from the baseline to 8 weeks and 12 weeks to evaluate the activity of knee joint | baseline to 8 weeks and 12 weeks | No |
Secondary | 40m FPWT score(40 meters fast walking test) | Changes from the baseline to 8 weeks and 12 weeks to evaluate the activity of knee joint | baseline to 8 weeks and 12 weeks | No |
Secondary | Assessment score under ultrasound | Changes from the baseline to 8 weeks and 12 weeks to evaluate the changes of patients' inner-structure of knee | baseline to 8 weeks and 12 weeks | No |
Secondary | Assessment score under MRI | Changes from the baseline to 8 weeks and 12 weeks to evaluate the changes of patients' inner-structure of knee | baseline to 8 weeks and 12 weeks | No |
Secondary | TNF-a?IL1-a?IL1-ß?MMP1?MMP13 level in serum | Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level | baseline to 8 weeks and 12 weeks | No |
Secondary | SF-12 score(MOS 12-item Short Form Health Survey) | Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' health condition | baseline to 8 weeks and 12 weeks | No |
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