NCT03639740Unknown4 期
TReat-to-tArget (T2T) With seCukinumab in Axial Spondyloarthritis. IdEntification of MRI and Biochemical Biomarkers for Disease Activity, Treatment Response and Structural Damage Progression (the TRACE Study)
Professor Mikkel Østergaard10 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Proportion of patients with a positive change in MRI-inflammation
研究概览
简要总结
A study of axSpA and AS receiving Secukinumab in a treat-to-target strategy.
详细描述
Comparison of reductions in MRI inflammation in the sacroiliac joints and spine from week 16 to 24 in patients who at week 16 are in ASDAS remission (i.e. continue sc. secukinumab 150 mg monthly) vs. not in ASDAS remission (i.e. increase sc. secukinumab 300 mg monthly). ASDAS remission is defined as ASDAS inactive disease i.e. ASDAS<1.3.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of axial spondyloarthritis (axSpA) according to the ASAS (Assessment of Spondyloarthritis International Society) criteria and/or ankylosing spondylitis (AS) according to the modified New York criteria as judged by a spondyloarthritis (SpA) rheumatologist (regarding imaging in the criteria, see below).
- •Active inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert.
- •Active disease defined as ASDAS ≥ 2.1 (ASDAS high disease activity).
- •Total back pain as measured on a visual analogue scale (VAS) scale ≥ 4 0 mm (0-100 mm) at baseline.
- •Clinical indication for a biologic drug as assessed by the treating physician.
- •Patients should have received at least 2 different NSAIDs at the highest recommended dose for at least 2 weeks each with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications.
- •Patients on NSAIDs at inclusion should stay on a stable dose from at least 2 weeks before the baseline MRI scans are performed and to the week 24 visit.
- •Patients on synthetic disease-modifying anti-rheumatic drugs (sDMARDs) at inclusion should stay on a stable dose from at least 4 weeks before initiation of secukinumab to the week 24 visit.
- •Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed.
- •Male or female patients at least 18 years and less than 70 years of age.
- •Sufficient contraception for women.
- •Age ≥18 to <70 years.
- •Capable of giving informed consent.
- •Capable of complying with the examination programme of the protocol.
排除标准
- •Contraindications for secukinumab (described in protocol).
- •Contraindication for TNF inhibitor (described in protocol).
- •Contraindication for MRI (described in protocol).
- •Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 or interleukin-17 receptor.
- •Previous exposure to TNF inhibitor or drug targeting TNF.
- •Previous exposure to other types of biological disease-modifying anti-rheumatic drugs (bDMARDs) than TNF inhibitor.
- •Patients taking high-potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- •Any change in the dose of oral corticosteroids in the last 8 weeks prior to the baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 8 weeks prior to the enrollment visit.
- •Use of any investigational drug and/or devices within 4 weeks before randomization or a period of 5 half-lives of the investigational drug, whichever is longer.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU).
- •Known recent drug or alcohol abuse.
- •Incapable of complying with the examination programme for physical or mental reasons.
- •Failure to provide written consent
研究组 & 干预措施
Secukinumab 150 mg 300 mg or tumor necrosis factor inhibitor
Other
Secukinumab 150 mg sc. injection once a week for four weeks (induction phase) and thereafter once a month. If patients do not achieve ASDAS remission they get increased dosage of Secukinumab 300 mg sc. injection once a month. If still no ASDAS remission patients change to a TNF-inhibitor
干预措施: Secukinumab 150 milligram [Cosentyx] (Drug)
结局指标
主要结局
Proportion of patients with a positive change in MRI-inflammation
时间窗: Comparison of week 16 and 24
Assessed with the sum of SPARCC MRI SIJ and spine inflammation indices
次要结局
- Changes in scores/anatomical location of MRI lesions in the spine(week 16)
- Proportion of patients in remission vs patients not in ASDAS (Ankylosing Spondylitis Disease Activity Score) remission.(Comparison of week 16 and 24)
- Changes in ASDAS score (i.e. Ankylosing Spondylitis Disease Activity Score (ASDAS 0.6-7.0))(Evaluated from week 0 to 16 and from week 16 to 24)
- Changes in MRI inflammation scores from week 0 to 16 and week 16 to 24, respectively.(Week 0 to 16 and week 16 to 24)
- Changes in scores/anatomical location of MRI lesions in the SIJs(week 16)
- MRI inflammation(week 16)
研究者
Professor Mikkel Østergaard
Professor, DMSc, PhD, MD
Rigshospitalet, Denmark
研究点 (10)
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