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临床试验/NCT00726804
NCT00726804终止4 期

Discontinuation of TNF-alpha Inhibitors in Spondylarthritis Patients With Low Disease Activity, and Re-initiation of Therapy if Disease Flares

Glostrup University Hospital, Copenhagen4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
7
试验地点
4
主要终点
Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors

研究概览

简要总结

Spondylarthropathy (SpA) comprises a group of rheumatic diseases mainly affecting the spine and sacroiliac joints. In most of the patients disease activity alternates, and some patients have symptom free periods. Tumor-Necrosis-Factor-alpha (TNF-alpha) antagonists have significantly improved the treatment options for patients with spondyloarthritis. TNF-alpha antagonist therapy is costly, implies an increased risk of infections, including reactivation of tuberculosis, and the risk of long-term adverse events, as cancer, is fully clarified. It is highly relevant to explore to which extent anti-TNF-alpha therapy can be discontinued in SpA patients without immediate relapse of disease activity. Two studies have investigated discontinuation of a TNF-alpha antagonist (infliximab and etanercept) in ankylosing spondylitis, reporting flares in the majority of patients within the 1-year follow-up period, with the longest times to relapse in patients with the lowest disease activity. The effect of adalimumab discontinuation has never been studied, and, furthermore, the effect of TNF-alpha-antagonist discontinuation has never been studied in patients with early spondyloarthritis not fulfilling the New York criteria.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 12 months of treatment with infliximab, etanercept and adalimumab.
  • Diagnosis of spondylarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria or modified New York Criteria
  • No clinical active disease, defined as a BASDAI score <
  • Among other issues: Age >18 years; written informed consent, adequate birth control; no contraindications for anti-TNF-alpha-therapy

排除标准

  • Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
  • Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
  • Pregnancy or lactation
  • HIV, hepatitis B or C, tuberculosis, other infections
  • Malignancies
  • Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
  • Contraindications to anti-TNF-alpha-therapy
  • Contraindications to MRI

研究组 & 干预措施

2

Other

干预措施: Discontinuation of TNF-alpha inhibitor and re-starting it if flare-up in disease activity (etanercept or adalimumab) (Drug)

结局指标

主要结局

Flair-up in disease activity in axial arthritis and therapeutic response at re-starting TNF-alpha inhibitors

时间窗: 40 weeks

次要结局

  • Bath ankylosing spondylitis disaease activity score, Bath ankylosing spondylitis functional index, Bath ankylosing spondylitis metrology index, C-Reactive protein, MRI, biomarkers of inflammation, cartilage and bone turnover(40 weeks)

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

MOstergaard

Professor

Glostrup University Hospital, Copenhagen

研究点 (4)

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