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Efficacy and safety of Etanercept (Recombinant Human Tumor Necrosis Factor-a Receptor?:IgG Fc Fusion Protein for Injection) in the treatment of knee osteoarthritis

Efficacy and safety of Etanercept (Recombinant Human Tumor Necrosis Factor-a Receptor?:IgG Fc Fusion Protein for Injection) in the treatment of knee osteoarthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101334
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory knee osteoarthritis

Interventions

treatment group:Etanercept
control group:Nonsteroidal anti-inflammatory drugs

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
38 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Ages 38 to 70, no gender restrictions. 2.The diagnosis meets the classification criteria for knee osteoarthritis revised in 1995 by the American College of Rheumatology.. 3.The patient agrees to the study treatment protocol, understands the trial procedures and content, and voluntarily signs the informed consent form to indicate their willingness to participate in the trial. 4.Based on the ROAMES score, the target joint belongs to patients with inflammatory osteoarthritis. 5.Eligibility for DMARDs can be determined through a tuberculosis screening and an evaluation by a physician.

Exclusion criteria

Exclusion criteria: 1.Knee X-ray evaluation shows a K-L grade IV. 2.RF or anti-CCP antibody levels exceed twice the normal upper limit; Anti-nuclear antibodies >= 1:320. 3.Combining infectious arthritis, gout, spondyloarthritis, or seronegative rheumatoid arthritis. 4.Positive for hepatitis B surface antigen or alanine aminotransferase or creatinine levels greater than 1.5 times the upper limit of normal. 5.Pregnant or breastfeeding women; 6.Patients with late-stage osteonecrosis, severe knee valgus or varus deformities, severe subchondral cystic lesions, or fractures of the femur or tibia. 7.Patients who have used DMARDs or medications containing chondroitin sulfate, glucosamine, or diacerein within the last three months, or who have received hyaluronic acid or corticosteroid joint cavity treatments in the past four weeks.

Design outcomes

Primary

MeasureTime frame
level of pain;

Countries

China

Contacts

Public ContactHelan

The First Affiliated Hospital of Xi'an Jiaotong University

Xajdhl87@mail.xjtu.edu.cn+86 29 8532 3215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026