Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

NCT03880968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 311

Last updated 2021-07-01

No results posted yet for this study

Summary

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

Conditions

  • Spondylitis, Ankylosing

Interventions

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).

Sponsors & Collaborators

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    collaborator OTHER
  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Affiliated Hospital of Jiaxing University

    collaborator OTHER
  • Shaoxing Second Hospital

    collaborator OTHER
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER
  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV
  • Wenzhou Central Hospital

    collaborator OTHER
  • Zhejiang Provincial People's Hospital

    collaborator OTHER
  • Shaoxing People's Hospital

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-01
Primary Completion
2014-09-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880968 on ClinicalTrials.gov