Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28
研究概览
简要总结
The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.
详细描述
In the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen.
After 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must:
- •be 18 to 48 years of age
- •have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years.
- •have active disease during trial enrollment
- •have limited treatment history for axial spondyloarthritis (must meet certain criteria)
- •agree to an acceptable method of contraception (for women of childbearing potential and all men)
- •must meet certain tuberculosis screening requirements
- •must meet certain laboratory screening safety requirements
- •have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the Screening visit if site is outside of Germany).
排除标准
- •Participant will be excluded:
- •for certain medical conditions and/or recent history of certain medical disorders
- •for current or recent treatment with certain other medications and certain vaccinations.
- •for being a woman who is breastfeeding, pregnant, or intending to become pregnant.
- •if known to have had a substance abuse problem within the previous 3 years prior to screening.
- •if currently participating in any other clinical study.
- •for other administrative reasons.
研究组 & 干预措施
Infliximab + Naproxen
Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
干预措施: Infliximab (Drug)
Infliximab + Naproxen
Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
干预措施: Naproxen (Drug)
Placebo + Naproxen
Placebo administered intravenously on Day 1 at Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
干预措施: Placebo (Drug)
Placebo + Naproxen
Placebo administered intravenously on Day 1 at Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
干预措施: Naproxen (Drug)
Naproxen Only (Follow-Up)
For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
干预措施: Naproxen (Drug)
结局指标
主要结局
Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28
时间窗: Week 28
ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).
次要结局
- Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase(Week 52)
- Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28(Baseline, Week 28)
- Change From Baseline in the Sacroiliac Overall Score at Week 28(Baseline, Week 28)
- Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase(Week 52)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52(Week 52)
- Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase(Week 52)
- Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase(Week 52)
- Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase(Week 28)
- Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase(Week 28)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28(Week 28)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28(Week 28)
- Change From Baseline of Berlin MRI Spine Overall Score at Week 52(Baseline, Week 52)
- Change From Baseline in the Sacroiliac Overall Score at Week 52(Baseline, Week 28)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28(Week 28)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52(Week 52)
- Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52(Week 52)