Evaluation of Clinical Value of Standardized Protocol for Dose-reduction in Patients With Spondylarthropathies and Clinical Remission With Anti-TNF Therapy: Open-label, Controlled, Randomized, Multicenter Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 31
- 主要终点
- Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
研究概览
简要总结
The purpose of this study is to demonstrate that patients with Spondylarthropathies in remission under antiTNF therapy, can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule.
详细描述
It has been shown that the withdrawal of treatment follows with a flare of the disease in a short time after the suspension but it has not been evaluated in controlled trials if remission could be maintained with a lower dose. A multicenter, national, open-label, randomized and controlled clinical trial of 3 years duration (2 years for inclusion + 1 year follow-up) is proposed to address this issue. The study will include 190 patients with Spondylarthropathies in stable treatment with any single anti-TNF agent and compliance with criteria of clinical remission for at least 4 months. Patients will be randomized to intervention or control arm, with stratification according to the antiTNF product thet were receiving prior to inclusion. Patients will be followed with the calendar of visits recommended by the Spanish Society of Rheumatology for clinical practice. The proposed hypothesis is of non-inferiority of the experimental arm with dose reduction versus the control arm with standard treatment.
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
- 否
入选标准
- •Patients older than 18 years
- •Patients with Spondylarthropathies according ASAS group criteria.
- •Patients under treatment with anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab) who present established clinical remission
- •Patients to give their informed consent to participate in the study
排除标准
- •Patients with secondary Spondylarthropathies
- •Patients with Spondylarthropathies and predominantly clinical of peripheral arthritis which receive anti-TNF therapy by peripheral symp tons.
- •Patients with Spondylarthropathies and other associated diseases that hinders or modify the clinical evaluation of the patient (fibromyalgia, chronic inflammatory disorders...)
- •Patients with bowel inflammatory disease
- •Patients under chronic therapy with anti-TNF therapy who received the patterns of reduction that will be explored in the experimental group, or low doses or most spaced that those in the experimental group before study inclusion
研究组 & 干预措施
Stable doses of anti-TNF
Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis
干预措施: Stable doses of anti-TNF (Drug)
Reduced doses of anti-TNF
Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab
干预措施: Reduced doses of anti-TNF (Drug)
结局指标
主要结局
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Rheumatology Society (SER) consensus, after one year
时间窗: one year after inclusion
Proportion of patients who are kept in the acceptable therapeutic objective according Spanish Society of Reumatology (SER) consensus (BASDAI \< 4, global clinical impression by physician \<4 and by patient \< 4 and axial nocturnal pain \<4) after one year
次要结局
- Proportion of patients who experience a clinical reactivation(last study visit (up to 3 years or December 2014))
- Proportion of patients who are kept in the acceptable therapeutic objective in the last study visit(last study visit (up to 3 years or December 2014))
- Proportion of patients who are kept in the ideal therapeutic objective in the last follow visit(last study visit (up to 3 years or December 2014))
- Time to clinical reactivation(last study visit (up to 3 years or December 2014))
- Withdrawal because of clinical requirement to modify the antiTNF treatment.(last study visit (up to 3 years or December 2014))
- NSAIDs use(last study visit (up to 3 years or December 2014))
- Suspected Serious Adverse Reactions(last study visit (up to 3 years or December 2014))
- Time to Suspected Serious Adverse Reaction(last study visit (up to 3 years or December 2014))
- Proportion of patients in remission one year after inclusion in the study(one year)
- Proportion of patients in remission after two years from inclusion in the study(2 years)
研究者
Dra. Caridad Pontes
Study coordinator
Spanish Clinical Pharmacology Society