Remicade in the Treatment of Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Bath AS disease activity score (BASDAI)
研究概览
简要总结
The aim of the study was to evaluate the efficacy of infliximab (IFX) treatment, 5 mg/kg every 6 weeks, in patients with active ankylosing spondylitis (AS) and to determine whether IFX dose reduction and interval extension, 3 mg/kg every 8 weeks during the second year sustained the treatment effect. The study was started in 2003 an finished in 2008.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients had to fulfill the following four inclusion criteria:
- •(I) Age between 18 and 60 years, (II) proven diagnosis according to the modified New York criteria 12 for definitive AS, (III) active disease with Bath AS Disease Activity Index (BASDAI) score above 4 and (IV) current or previous treatment with conventional non-steroidal anti-inflammatory drugs (NSAID) in adequate doses without sufficient effect.
排除标准
- •current signs or symptoms of severe, progressive or uncontrolled hepatic, hematological, pulmonary, cardiac, neurological or cerebral disease;
- •ongoing or past serious infection (including HIV and past or current tuberculosis);
- •pregnancy or breast feeding;
- •current malignancy or history of malignancy within the past five years;
- •congestive heart failure and any contraindication to MRI.
研究组 & 干预措施
Infliximab
Patients with active AS defined as BASDAI score above 4 and no exclusion criteria were consecutively included in this single-armed unblinded trial.
干预措施: Infliximab (Drug)
结局指标
主要结局
Bath AS disease activity score (BASDAI)
时间窗: 16 weeks
The proportion of responders at week 16 defined as a reduction of 50% and/or 2 units improvement from baseline of Bath AS disease activity score (BASDAI)
次要结局
未报告次要终点
研究者
Helena Forsblad d'Elia
MD, PhD
Göteborg University