2023-508976-12-00招募中4 期
Rapid pain control in Ixekizumab targeted axial spondyloarthritis
Universitaetsklinikum Erlangen AöR1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年1月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in fMRI BOLD signal voxel count during initial treatment with Ixekizumab (day 17 vs. day 14) as compared to change in fMRI BOLD signal voxel count during pre-treatment (day 3 vs. day 0)
研究概览
简要总结
To evaluate early CNS pain response detected by BOLD signal changes in fMRI of the brain to Ixekizumab treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •male or female subject aged ≥ 18 years at time of consent
- •negative pregnancy test in women of childbearing potential (WOCBP) and willing to use at least 1 acceptable method of contraception throughout trial participation and for at least 10 weeks after treatment period
- •understand and voluntarily sign informed consent form
- •able to follow trial instructions and likely to attend and complete all required visits
- •fulfils ASAS classification criteria for axSpA
- •VAS pain (0 - 10) > 4
- •indication for systemic treatment with bDMARDs (active disease, inadequate response to 2 NSAIDs at maximum tolerable dosage)
- •current NSAID and/or analgesic therapy at stable dose for at least 2 weeks prior to screening and maintenance for the duration of the trial (if applicable)
- •current Glucocorticoids treatment (≤ 10 mg/day) at stable dose for at least 4 weeks prior to screening and maintenance for the duration of the trial (if applicable)
排除标准
- •prior exposure to bDMARDs
- •history of or presence of inflammatory bowel disease including Crohn’s disease and ulcerative colitis
- •Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
- •Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
- •Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
- •treatment with Glucocorticoids of more than 10 mg/day
- •previous Ixekizumab treatment within 4 weeks (or 5 half-lives, whichever is longer) prior to enrolment
- •any contraindication to perform MRI
- •any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon Tb-test. (if presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment) or history of recurrent infections
- •any other autoimmune or inflammatory disease (e.g. but not limited to RA, SLE, SSc, MCTD, Behcet disease, vasculitis, or autoimmune hepatitis)
- •presence of fibromyalgia or other forms of widespread pain at the discretion of the investigator
- •requirement for immunization with live vaccine during trial participation or within the four weeks prior to screening
- •history of venous thrombosis or pulmonary embolism
- •any condition, including the presence of laboratory abnormalities, which would impact the safety of the subject or the interpretation of the trial results
结局指标
主要结局
Change in fMRI BOLD signal voxel count during initial treatment with Ixekizumab (day 17 vs. day 14) as compared to change in fMRI BOLD signal voxel count during pre-treatment (day 3 vs. day 0)
Change in fMRI BOLD signal voxel count during initial treatment with Ixekizumab (day 17 vs. day 14) as compared to change in fMRI BOLD signal voxel count during pre-treatment (day 3 vs. day 0)
次要结局
未报告次要终点
研究者
PD Dr. med. Jürgen Rech
Scientific
Universitaetsklinikum Erlangen AöR
研究点 (1)
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