Clinical Trials Logo
  1. Home
  2. Spondylitis, Ankylosing
  3. NCT03880968

Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis — T2TEAS  

Spondylitis, Ankylosing Clinical Trial

Official title:
Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis: a Prospective, Randomized Multicentric Study on Disease Activity Guided Etanercept Tapering or Discontinuation

Clinical Trial Summary

Evaluate the disease activity guided tapering and discontinuation strategies of etanercept (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.

Clinical Trial Description

Ankylosing spondylitis (AS), a subset of axial spondyloarthritis (axSpA), is a chronic inflammatory disorder characterized by inflammatory back pain and predominant involvement of sacroiliac joints and spine, leading to bony fusion of vertebrae and eventually disability in some patients. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recognized as a first-line therapy for AS, but the overall response rates to NSAIDs are considerably unsatisfactory. With the advent of biologics, the outcomes of AS patients have been greatly improved. Biologics including tumor necrosis factor α (TNFα) inhibitors (TNFi) have been included in many recommendations for the treatment of AS. Etanercept, a recombinant human TNFα receptor, is capable of binding to TNFα and blocking its biological activities. It is effective in relieving symptoms, improving physical function, and reducing disease activity in patients with AS, and generally no severe adverse effects have been reported. However, the high expense of biologics restricts their long-term use, which urges a viable strategy to reduce the dosage of biologics while maintaining an optimal therapeutic efficacy. To investigate the stepwise tapering and discontinuation of TNFi based on disease activity in patients with AS, a 48-week, prospective, randomized, multicentric study was conducted. An etanercept biosimilar, rhTNFR:Fc (recombinant TNF receptor: Fc fusion protein, Yisaipu), which is one of the most widely used biosimilars in China, was used in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03880968
Study type Observational
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact
Status Completed
Phase
Start date March 1, 2012
Completion date September 30, 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT01208207 - A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) Phase 3
Completed NCT02509026 - Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA Phase 4
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Terminated NCT01209702 - A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs Phase 3
Terminated NCT01209689 - A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy Phase 3
Terminated NCT00766402 - An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) Phase 4
Completed NCT00000433 - Blocking Tumor Necrosis Factor in Ankylosing Spondylitis Phase 2
Completed NCT00779935 - Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED) Phase 4
Completed NCT00779012 - A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED) Phase 4
Completed NCT01863732 - Extension in AS: Sustainability of Benefits, Safety and Tolerability Phase 3
Recruiting NCT05879419 - Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Phase 4
Completed NCT01567878 - Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects N/A
Completed NCT01188655 - Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis N/A
Completed NCT00760669 - An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants Phase 4
Completed NCT02159053 - 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT00202865 - Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352) Phase 3
Completed NCT02374502 - Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial N/A
Withdrawn NCT00298012 - Methotrexate in the Treatment of Axial Spondyloarthritis Phase 4
Terminated NCT00273858 - Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis N/A
Completed NCT04810715 - Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis