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

NCT02722772 | Unknown DMC

• 1 other identifier: IAI-ETN-KOA-201613
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aim: evaluate efficacy of intra-articular 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 intra-articular injection of etanercept for moderate and severe knee osteoarthritis.

Conditions

Osteoarthritis of Knee

Keywords

Intra-Articular Injection; Etanercept; TNF-α; IL-1; Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (10)

• 30s-CST score(30 seconds Sit/chair Test)

  baseline to 8 weeks and 12 weeks

• 40m FPWT score(40 meters fast walking test)

  baseline to 8 weeks and 12 weeks

• Assessment score under ultrasound

  baseline to 8 weeks and 12 weeks

• Assessment score under MRI

  baseline to 8 weeks and 12 weeks

• TNF-α (pg/ml) level in serum

  baseline to 8 weeks and 12 weeks

Other Outcomes (1)

• Adverse event

  2 weeks, 4 weeks, 8 weeks and 12 weeks

Study Arms (2)

Etanercept treatment group

EXPERIMENTAL

Intra-articular injection of etanercept of 25 mg/w/joint and Health education, exercise and diet guidance; treatment: 5 weeks (If both knees are involved, the more significant symptomatic side is chosen for injection by etanercept)

Drug: Etanercept; Other: Health education, exercise and diet guidance

Routine care group

PLACEBO COMPARATOR

Health education, exercise and diet guidance; treatment: 5 weeks

Other: Health education, exercise and diet guidance

Interventions

Etanercept DRUG

Intra-articular injection of etanercept of 25mg/w/joint for 5 weeks.

Etanercept treatment group

Health education, exercise and diet guidance OTHER

Health education, exercise and diet guidance in patient; treatment: 5 weeks

Etanercept treatment group; Routine care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give full consent;
• According with classification of "Clinical Image" of 1986 American college of rheumatology criteria in osteoarthritis of the knee ;
• Grade II-III of Kellgren-Lawrence (KL) grading system, revealing synovial inflammation or synovial fluid by combining ultrasound and/or MRI
• Knee pain for at least 1 Month and Pain VAS Score\>4 during the last week;
• Fertile women agreed to adopt effective contraceptive measures during the test.

You may not qualify if:

• Allergic to pharmaceutical ingredients;
• Received Tumor Necrosis Factor inhibitor (TNFI) or other biologics preparation within 3 months;
• Received physical therapy or articular injection, taking antidepressants or antispasmodic, opioids within 3 months ;
• Patients with history of knee surgery or upcoming surgery within 10 years;
• Patients accompanied by other complications or joint disease (such as septic arthritis, osteonecrosis,haemochromatosis, ochronosis, etc.);
• Patients with serious joint deformation or joint deformities;
• Patients with active or a history of recurrent infections;
• Patients existing active tuberculosis (TB) or has a history of active TB;
• Patients with positive on hepatitis b surface antigen or hepatitis c antibody;
• Patients with a history of severe lung disease, tumor;
• Patients with severely abnormal function on liver and kidney (liver enzyme \> = 2 times normal, creatinine \> = normal);
• Patients with pregnancy, ready for pregnancy or lactation;
• Patients with other conditions which not suitable for use of Etanercept.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead
• Shanghai baiying pharmaceutical technology Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Etanercept; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zhiyi Zhang

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

• Yifang Mei, M.D

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyi Zhang, Ph.D

CONTACT

+86-451-85552350; zhangzhiyi_rheu@163.com

Yifang Mei, M.D

CONTACT

+86-451-85552350; myfyxd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 8, 2016

Record last verified: 2016-02

Locations

CN (1)