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Search / Trial NCT02722772

Efficacy of Intra-Articular Injection of Etanercept for Moderate and Severe Knee Osteoarthritis

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

Trial Information

Current as of April 25, 2025

Unknown status

Keywords

Intra Articular Injection Etanercept Tnf α Il 1 Osteoarthritis Of Knee

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. \[1\]

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 ...

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-III of Kellgren-Lawrence (KL) grading system, revealing synovial inflammation or synovial fluid by combining ultrasound and/or MRI
  • 4. Knee pain for at least 1 Month and Pain VAS Score\>4 during the last week;
  • 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 serious joint deformation or joint deformities;
  • 7. Patients with active or a history of recurrent infections;
  • 8. Patients existing active tuberculosis (TB) or has a history of active TB;
  • 9. Patients with positive on hepatitis b surface antigen or hepatitis c antibody;
  • 10. Patients with a history of severe lung disease, tumor;
  • 11. Patients with severely abnormal function on liver and kidney (liver enzyme \> = 2 times normal, creatinine \> = normal);
  • 12. Patients with pregnancy, ready for pregnancy or lactation;
  • 13. Patients with other conditions which not suitable for use of Etanercept.

About First Affiliated Hospital Of Harbin Medical University

The First Affiliated Hospital of Harbin Medical University is a leading clinical research institution dedicated to advancing healthcare through innovative medical studies and trials. As a prominent teaching hospital in China, it combines cutting-edge research with comprehensive patient care, facilitating a robust environment for clinical investigations across various medical disciplines. The hospital is committed to improving clinical outcomes and enhancing patient safety, fostering collaboration among healthcare professionals, researchers, and industry partners. With a focus on translating research findings into practice, the First Affiliated Hospital plays a vital role in the development of new treatments and therapies, contributing to the global body of medical knowledge.

Locations

Harbin, Heilongjiang, China

Patients applied

0 patients applied

Trial Officials

Zhiyi Zhang

Study Chair

First Affiliated Hospital of Harbin Medical University

Yifang Mei, M.D

Principal Investigator

First Affiliated Hospital of Harbin Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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