An observational study in Spondylitis, Ankylosing, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-01.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
Evaluate the disease activity guided tapering and discontinuation strategies of etanercept (ETN) in patients with ankylosing spondylitis (AS) in 48 weeks.
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 311 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Patients with AS were recruited in this study. Eligible patients were aged between 18 years old and 65 years old, and were diagnosed with AS according to 1984 revised New York classification criteria. Only patients meet both inclusion and exclusion criteria were included.
Exclusion Criteria:
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who achieved inactive disease (ASDAS\<1.3, group A) at week 12 and assigned to sequential tapering group (A1).
Drug: tapering or discontinuation of etanercept
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who achieved inactive disease (ASDAS\<1.3, group A) at week 12 and then assigned to discontinuation group (A2).
Drug: tapering or discontinuation of etanercept
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS\<2.1, group B) and designated to sequential tapering group (B1).
Drug: tapering or discontinuation of etanercept
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS\<2.1, group B) and designated to delayed tapering group (B2) with extra 12 weeks of full dose ETN.
Drug: tapering or discontinuation of etanercept
Active AS patients with AS disease activity score (ASDAS)≥2.1 were recruited from ten hospitals, initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients in this arm were those who reached low disease activity (LDA) (1.3≤ASDAS\<2.1, group B) and designated to discontinuation group (B3).
Drug: tapering or discontinuation of etanercept
Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS\<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS\<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).
Also known as: rhTNFR:Fc, Yisaipu
Cumulative flare rates at week 48 with different tapering or discontinuation strategies
Cumulative flare rates at week 48 with different tapering or discontinuation strategies
Time frame: 48 weeks
No study locations are listed for this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University