Overview

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

Status:
Unknown status

Trial end date:
2017-08-01

Target enrollment:
0

Participant gender:
All

Summary

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, Interleukin 1-α (IL1-α), IL1-β, matrix metalloproteinases1 (MMP1), MMP13) to predict the response of subcutaneous injection of etanercept for moderate and severe knee osteoarthritis.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

First Affiliated Hospital of Harbin Medical University

Collaborator:

Shanghai Baiying Medical Technology Co., Ltd.

Treatments:

Etanercept

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.