NCT07770646尚未招募4 期
A Pragmatic Randomized Pilot Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility as determined by ≥80% retention of randomized participants
研究概览
简要总结
The purpose of this study is to determine the feasibility of conducting a pragmatic trial of IL-17i versus JAKi in adults with axial spondyloarthritis (axSpA) who have failed at least one tumor necrosis factor-alpha inhibitor (TNFi), to estimate the effectiveness of IL-17i versus JAKi at 16 weeks and to determine additional effectiveness measures, safety, and treatment persistence of IL-17i versus JAKi
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
- Single (Outcomes Assessor)
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
- •fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS
- •Active axSpA (ASDAS ≥ 2.1 and/or BASDAI ≥ 4)
- •Failure of or intolerance to ≥1 TNF
- •Participants of reproductive potential must agree to use any form of effective contraception during the study period, in accordance with standard clinical practice and FDA labeling for the assigned study medication
- •Ability to provide informed consent
排除标准
- •Previously received an IL-17i or JAKi
- •Active infection requiring antimicrobials
- •Contraindications to either treatment arm:
- •Inflammatory bowel disease (IBD)- Crohn's disease or Ulcerative Colitis
- •Active cancer or cancer remission within the past 3 years (apart from non-melanoma skin cancer (NMSC) and cervical intraepithelial neoplasia (CIN)
- •History of stroke, heart attack, or blood clots (venous or arterial)
- •Cirrhosis
- •End-stage renal disease (GFR <15) or dialysis
- •Human Immunodeficiency Virus (HIV) positive
- •Pregnant or lactating
- •Concomitant use of other biologic or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) therapy
研究组 & 干预措施
Upadacitinib (JAKi)
Experimental
干预措施: Upadacitinib (JAKi) (Drug)
Secukinumab (IL-17i )
Experimental
干预措施: Secukinumab (IL-17i ) (Drug)
结局指标
主要结局
Feasibility as determined by ≥80% retention of randomized participants
时间窗: end of treatment (week 16)
Feasibility as determined by ≥90% completeness of primary clinical data
时间窗: end of treatment (week 16)
Feasibility as determined by enrollment of ≥60% of eligible patients
时间窗: end of treatment (week 16)
Change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) reported as a mean (SD)
时间窗: Baseline, week 16
This is a 4 item questionnaire and one lab result (CRP). The first 4 questions are scored from 0-10. The result is a single numerical score, typically ranging from about 0 to 6, with higher scores indicating more active disease.
次要结局
- Percentage of participants that have an ASDAS score of <2.1 and ≥2.1(end of treatment (week 16))
- Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score(end of treatment (week 16))
- Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score(end of treatment (week 16))
- Number of participants in the different categories of disease activity as assessed by the ASDAS(end of treatment (week 16))
- Percentage of participants in the different categories of disease activity as assessed by the ASDAS(end of treatment (week 16))
- Number of participants that have an ASDAS score of <2.1 and ≥2.1(end of treatment (week 16))
- Change in patient global disease activity measured as a mean (SD)(Baseline, week 16)
- Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measured as a mean (SD)(Baseline, Week 16)
- Change in physical functioning as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) measured as a mean (SD)(Baseline, week 16)
- Number of participants who met the Assessment of SpondyloArthritis International Society 20% response (ASAS20) criteria(end of treatment (week 16 ))
- Percentage (%) of participants who met the ASAS20 response criteria(end of treatment (week 16))
- Number of participants who met the Assessment of SpondyloArthritis International Society 40% response (ASAS40) criteria(end of treatment (week 16))
- Percentage of participants who met the ASAS40 response criteria(end of treatment (week 16))
- Number of patients who had an occurrence of acute anterior uveitis (AAU) episode since starting treatment(Baseline to week 16)
- Change in the impact of axSpA on health and functioning as assessed by the ASAS Health Index (ASAS HI) measured as a mean (SD)(Baseline, week 16)
- Number of patients with improvement ≥3 on the ASAS HI score(end of treatment (week 16))
- Percentage of patients with improvement ≥3 on the ASAS HI score(end of treatment (week 16))
- Change in peripheral joint inflammation as assessed by the 44 Tender Joint Count (TJC44) measured as a mean(SD)(Baseline, week 16)
- Change in peripheral joint inflammation as assessed by the 44 Swollen Joint Count (SJC44) measured as a mean(SD)(Baseline, week 16)
- Percentage of patients who had an occurrence of acute anterior uveitis (AAU) since starting treatment(Baseline to week 16)
- Change in peripheral joint inflammation assessed by the Disease Activity Index for Psoriatic Arthritis (DAPSA44) measured as a mean (SD)(Baseline, week 16)
- Change in severity of enthesitis as assessed by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) measured as a mean (SD)(Baseline, week 16)
- Change in number of digits with active dactylitis as assessed by the Dactylitis Count measured as a mean(SD)(Baseline, week 16)
- Number of patients who developed psoriasis after starting treatment(Baseline to week 16)
- Percentage of patients who developed psoriasis after starting treatment(Baseline to week 16)
- Number of patients who developed Inflammatory Bowel Disease (IBD) during treatment(Baseline to week 16)
- Percentage of patients who developed Inflammatory Bowel Disease (IBD) during treatment(Baseline to week 16)
- Number of patients who had an adverse event by category during treatment(Baseline to week 16)
- Percentage of patients who had an adverse event by category during treatment(from baseline to week 16)
- Change in Erythrocyte Sedimentation Rate (ESR) measured as a mean(SD)(Baseline, week 16)
- Change in C-reactive Protein (CRP) measured as a mean(SD)(Baseline, week 16)
- Treatment persistence at week 52(End of study (week 52))
- Change in fatigue as assessed by BASDAI Q1 measured as a mean (SD)(Baseline, week 16)
- Change in total back pain as assessed by BASDAI Q2 measured as a mean (SD)(Baseline, week 16)
- Change in mean stiffness severity as assessed by BASDAI Q5 measured as a mean (SD)(Baseline, week 16)
- Treatment persistence at week 16(Week 16)
研究者
Savannah Bowman
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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