跳至主要内容
临床试验/NCT02469753
NCT02469753已完成3 期

Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes

University Hospital, Bordeaux27 个研究点 分布在 2 个国家目标入组 188 人开始时间: 2015年10月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
188
试验地点
27
主要终点
Proportion of patients who show a significant radiographic progression between the two randomised groups of patients

研究概览

简要总结

Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.

Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.

研究设计

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

入排标准

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

入选标准

  • Patients aged over 18 years old
  • Patients who fulfil 1984 modified New York criteria for ankylosing spondylitis:
  • SA patients with indications for anti-TNF treatment initiation according to the French society of Rheumatology guidelines.
  • Being affiliated to a health insurance system
  • Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)

排除标准

  • Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
  • Patients who present contraindications to treatment with NSAIDs.
  • Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day
  • Pregnant or breastfeeding women
  • Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing to undergo MRI
  • Women that refuse to an effective contraception method for all the study duration

研究组 & 干预措施

Patients treated with anti-TNF and continuous daily NSAIDs

Experimental

干预措施: NSAIDs (Drug)

Patients treated with anti-TNF and continuous daily NSAIDs

Experimental

干预措施: anti-TNF (Drug)

Patients treated with anti-TNF and NSAIDs on demand

Active Comparator

干预措施: NSAIDs (Drug)

Patients treated with anti-TNF and NSAIDs on demand

Active Comparator

干预措施: anti-TNF (Drug)

结局指标

主要结局

Proportion of patients who show a significant radiographic progression between the two randomised groups of patients

时间窗: 24 month after the begin of the treatment

次要结局

  • Radiologic evolution between-group comparison(At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment))

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (27)

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