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Efficacy of Subcutaneous Injection of Etanercept for Moderate and Severe Knee Osteoarthritis (ESIETNKOA)

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ClinicalTrials.gov Identifier: NCT02722811
Recruitment Status : Unknown
Verified February 2016 by First Affiliated Hospital of Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Shanghai Baiying Medical Technology Co., Ltd.
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Of Knee Drug: Etanercept Other: Health education, exercise and diet guidance Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Subcutaneous Injection of Etanercept for Moderate and Severe Knee Osteoarthritis
Study Start Date : February 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Etanercept treatment group
Subcutaneous injection etanercept of 50 mg/w and Health education, exercise and diet guidance; treatment: 8 weeks
Drug: Etanercept
etanercept of 50 mg/w, subcutaneous injection; treatment: 8 weeks

Other: Health education, exercise and diet guidance
Health education, exercise and diet guidance in patient; treatment: 8 weeks

Placebo Comparator: Routine care group
Health education, exercise and diet guidance; treatment: 8 weeks
Other: Health education, exercise and diet guidance
Health education, exercise and diet guidance in patient; treatment: 8 weeks




Primary Outcome Measures :
  1. Pain VAS score(Pain Visual Analogue Scale/Score) [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy

  2. KOOS score(The Knee injury and Osteoarthritis Score) [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the treatment efficacy


Secondary Outcome Measures :
  1. 30s-CST score(30 seconds Sit/chair Test) [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the activity of knee joint

  2. 40m FPWT score(40 meters fast walking test) [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the activity of knee joint

  3. Assessment score under ultrasound [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the changes of patients' inner-structure of knee

  4. Assessment score under MRI [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate the changes of patients' inner-structure of knee

  5. TNF-α (pg/ml) level in serum [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level

  6. IL1-α (pg/ml) level in serum [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level

  7. IL1-β (pg/ml) level in serum [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level

  8. MMP1 (ng/ml) level in serum [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level

  9. MMP13 (ng/ml) level in serum [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' inflammatory level

  10. SF-12 score(MOS 12-item Short Form Health Survey) [ Time Frame: baseline to 8 weeks and 12 weeks ]
    Changes from the baseline to 8 weeks and 12 weeks to evaluate patients' health condition


Other Outcome Measures:
  1. Adverse event [ Time Frame: 2 weeks, 4 weeks, 8 weeks and 12 weeks ]
    Type and frequency of adverse event



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722811


Contacts
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Contact: Zhiyi Zhang, Ph.D +86-451-85552350 zhangzhiyi_rheu@163.com
Contact: Yifang Mei, M.D +86-451-85552350 myfyxd@163.com

Locations
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China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Zhiyi Zhang, Ph.D    +86-451-85552350    Zhiyizhang_rheu@163.com   
Contact: Yifang Mei, M.D    +86-451-85552350    myfyxd@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Shanghai Baiying Medical Technology Co., Ltd.
Investigators
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Study Chair: Zhiyi Zhang, Ph.D First Affiliated Hospital of Harbin Medical University
Principal Investigator: Yifang Mei, M.D First Affiliated Hospital of Harbin Medical University

Publications:

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT02722811     History of Changes
Other Study ID Numbers: SI-ETN-KOA-201614
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not yet decided whether to share participants' data or not.

Keywords provided by First Affiliated Hospital of Harbin Medical University:
Etanercept
Osteoarthritis Of Knee
TNF-α
IL-1α
Subcutaneous Injection

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors