NL-OMON55923尚未招募2 期
A SINGLE ARM PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS USING AN ACTIVE IMPLANTABLE DEVICE - Splenic nerve stimulation in patients with rheumatoid arthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Adult-onset RA of at least six months duration as defined by the 2010
- •ACR/EULAR classification criteria.
- •* Male or female participants, 22-75 years of age inclusive at time of signing
- •* Participants must have active disease as defined by:
- •* At least 3 swollen joints
- •* A DAS-CRP>3.2 and/or CRP >15 mg/L.
- •* The participant must have an IR to at least two biologic DMARD and/or a JAKi.
- •Participants must have an appropriate washout as described below for previously
- •used biological DMARDs or JAKI.
- •Biologic agents:
- •* Anakinra, etanercept; adalimumab; Infliximab; certolizumab pegol, golimumab,
- •abatacept, tocilizumab, or other IL-6 blocking agents; tofacitinib,
- •baricitinib or other JAKI*s must be discontinued 2 weeks before surgery.
- •* Rituximab, or other selective B lymphocyte depleting agents 6 month prior to
- •* Any prior investigational treatment must be discontinued for 2 weeks or 2
- •half-lives, whichever is longer, prior to surgery.
排除标准
- •o Inability to provide IC.
- •o In the opinion of the PI significant psychiatric disease or substance abuse.
- •o History of unilateral or bilateral vagotomy.
- •o Evidence of active or latent (unless previously treated) tuberculosis
- •o Known infection with human immunodeficiency virus (HIV) or positive test at
- •o Current acute or chronic hepatitis B and/or C, or previous hepatitis B (Hep B
- •anti-core Ab+)
- •o Currently implanted electrically active medical devices (e.g., cardiac
- •pacemakers, automatic implantable cardioverter-defibrillators).
- •o Any investigational small molecule drug or biological within 2 weeks or 2
- •half-lives whichever is longer, before surgery.
- •o Uncontrolled other inflammatory diseases
- •o Current/recurrent infections that in the opinion of the PI risk>benefit.
- •o History of cancer within the past 5 years, except non-malignant skin cancer.
- •o Previous splenectomy.
- •o Participants with an abdominal wall thickness (AWT), epidermis to posterior
- •rectus sheath, greater than 2.5 cm based on ultrasound assessment or CT-scan.
- •o Chronic use of morphine or oxicodone.
- •Exclusion criteria related to the surgery and implant procedure:
- •o Type IV hiatal hernia and any hiatal hernia that produces a significant
- •distortion of the local anatomy, especially the pancreas and/or splenic artery.
- •o Gastric resection/mobilisation surgery with surgical access of the lesser sac.
- •o Celiac axis, aneurysms or anatomy associated with congenital anomalies of the
- •origin of the splenic artery.
- •o Splenic artery anatomical variants - splenic artery which is entirely within
- •the substance of the pancreas or the presence of the splenic artery aneurysms
- •or pseudoaneurysms.
- •o Participants who do not have a demonstrable clear plane between the pancreas
- •and the splenic artery, at the interface site, in the preoperative computed
- •tomography (CT) angiogram.
- •o Findings of cirrhosis or portal hypertension.
- •o Documented history of pancreatitis with significant peripancreatic
- •inflammation (CT evidence of necrosis, pseudocyst formation or significant
- •retroperitoneal calcification).
- •o Pancreatic abnormalities/mass/cyst/pseudocyst/lesions.
- •o Any condition per the investigator's clinical judgment that qualifies the
- •participant not fit for surgery.
- •o Body Mass Index (BMI) >= 33.
- •o Splenic artery diameter as accessed by CT angiography <3.0 mm or >7.4 mm.
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