A Multicenter and Observational Study to Assess the Effectiveness of Infliximab Comparing With Conventional Therapy in Ankylosing Spondylitis Subjects With Hip Involvement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 76
- 主要终点
- Change From Baseline in Harris Hip Score at Week 30
研究概览
简要总结
The purpose of this observational (a study that follows participants forward in time) study is to compare the functional improvement of hip joint using Harris hip score between 2 treatment groups (infliximab and conventional therapy) at Week 30 in ankylosing spondylitis (an autoimmune disease causing chronic inflammation at tendon ends and ligament attachment points) participants with hip involvement.
详细描述
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), observational study to compare the effectiveness of infliximab with conventional therapies in ankylosing spondylitis participants with hip joint involvement. The study will be conducted in 3 parts: a 14-day screening, a 30-week first follow-up (Follow-up 1), and an additional 22-week follow-up (Follow-up 2) up to Week 52. Participants will be assigned to two groups based on the current treatments they are receiving: cohort 1 participants receiving infliximab with or without combination of disease modifying drugs (DMARDs-such as Sulfasalazine, Methotrexate and Thalidomide) and/or non-steroidal anti-inflammatory drugs (NSAIDs) and in cohort 2 who are receiving DMARDs and/or NSAIDs for treatment of pain will be observed. Participants will primarily be assessed for change in harris hip score. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ankylosing spondylitis (AS) (according to the modified New York Criteria for AS) at least 3 months prior to the Day 1 in the Follow-up I phase with symptoms of active disease atScreening/Baseline
- •Hip pain and duration of hip symptom less than 2 years
- •Harris hip score less than (<) 70
- •Hip involvement proven by Magnetic resonance imaging (MRI)
- •Being treated with infliximab and conventional therapy for 2 weeks to 6 months
排除标准
- •Participant has a history of hip joint disability which was considered irreversible
- •Participant has a history of hip joint replacement
- •Participant has a history of treatment with biologics other than infliximab less than 6 months prior to study entry
研究组 & 干预措施
Cohort 1: Infliximab and/or NSAIDs and DMRADs
Participants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed.
干预措施: Infliximab (Drug)
Cohort 1: Infliximab and/or NSAIDs and DMRADs
Participants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed.
干预措施: NSAIDs (Drug)
Cohort 1: Infliximab and/or NSAIDs and DMRADs
Participants receiving intravenous infusion of infliximab with or without non-steroidal anti-inflammatory drugs (NSAIDs: aspirin, ibuprofen and naproxen) and Disease-modifying anti-rheumatic drugs (DMRADs: methotrexate (MTX), sulfasalazine, and thalidomide) will be observed.
干预措施: DMARDs (Drug)
Cohort 2: NSAIDs and DMARDs
Participants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed.
干预措施: NSAIDs (Drug)
Cohort 2: NSAIDs and DMARDs
Participants receiving NSAIDs (aspirin, ibuprofen and naproxen) and DMARDs (MTX, sulfasalazine, and thalidomide) will be observed.
干预措施: DMARDs (Drug)
结局指标
主要结局
Change From Baseline in Harris Hip Score at Week 30
时间窗: Baseline and Week 30
Harris hip score, a physician-assessed scoring method consisting of 10 items: pain, limp, support, distance walked, sitting, enter public transportation, stairs, put on shoes and socks, absence of deformity and range of motion. The scoring system covers domains like pain, function, absence of deformity and range of motion. The total Harris hip score has a maximum of 100 points with a higher score indicating a better hip function: Excellent (90-100), Good (80-89), Fair (70-79) and Poor (\<70).
次要结局
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Score at Week 30 and 52(Baseline, Week 30 and 52)
- Change From Baseline in Harris Hip Score at Week 14 and 52(Baseline, Week 14 and 52)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 30 and 52(Baseline, Week 30 and 52)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Week 30 and 52(Baseline, Week 30 and 52)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 30 and 52(Baseline, Week 30 and 52)
- Assessment of Improvement in Hip Joint(Baseline, Week 30 and 52)