NL-OMON52223招募中2 期
A MULTIPART EXPLORATORY STUDY TO EVALUATE SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS - Splenic nerve stimulation in patients with rheumatoid arthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
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
- •1. Adult-onset RA of at least six months duration as defined by the 2010
- •ACR/EULAR classification criteria.
- •2. Male or female participants, 22-75 years of age inclusive at time of signing
- •the informed consent.
- •3. Participants must have active disease as defined by at least 4 active
- •swollen and at least 4 active tender joints (based on 28 joint count) and CRP >=
- •4. The participant must have had an Inadequate Response to at least 2 biologic
- •DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor.
- •6. Participants must be receiving treatment with standard dose(s) of
- •conventional synthetic DMARD(s)
- •7. Demonstrate, or simulate, ability to use the Galvani System components by
- •8. For Female Participants Only: A female participant is eligible to
- •participate if she is not pregnant or breastfeeding or planning on becoming
- •pregnant in the future, and one of the following conditions applies: Is a woman
- •of non-childbearing potential OR Is a woman of childbearing potential (WOCBP)
- •and using an acceptable contraceptive method.
排除标准
- •1. Prior use of baricitinib or for whom baricitinib use is not recommended
- •2. Inability to provide informed consent.
- •3. Significant psychiatric disease or substance abuse.
- •4. History of unilateral or bilateral vagotomy.
- •5. Active or latent tuberculosis.
- •6. Known infection with human immunodeficiency virus (HIV); current acute or
- •chronic hepatitis B or hepatitis C; previous hepatitis B.
- •7. Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point
- •of screening for this study).
- •8. Currently implanted electrically active medical devices (e.g., cardiac
- •pacemakers, automatic implantable cardioverter-defibrillators).
- •9. Any prior investigational treatment (including small molecule drugs and/or
- •biologic therapies) must be discontinued for at least 4 weeks or 5 half-lives,
- •whichever is longer, prior to Day 1.
- •10. Patients with comorbid fibromyalgia.
- •11. Previous splenectomy.
- •12. Drug or alcohol abuse or dependence including opioid dependence or chronic
- •opioid use.
- •13. Laboratory exclusion criteria: cytopenia as characterized by - anemia
- •(hemoglobin < 8 g/dL), lymphopenia (ALC < 500 cells/mm3) and/or neutropenia
- •(ANC < 1000 cells/mm3).
- •14. Any finding - which in the opinion of the investigator would interfere with
- •the study interventions (including device implantation), study procedures
- •and/or assessments, or create an undue risk for the participant.
- •15. Exclusion criteria related to the surgery and implant procedure (Surgeon
- •Responsibility):
- •a. Patients with an epigastric abdominal wall thickness, epidermis to posterior
- •rectus sheath at the level of the linea alba, greater than 2 cm based on
- •screening ultrasound assessment and confirmed by CT-angiogram.
- •b. Patients with splenic artery luminal diameter greater than 7.4 mm or less
- •than 3.0 mm dimension on CT-angiogram.
- •c. Type IV hiatal hernia and any hiatal hernia that produces a significant
- •distortion of the local anatomy, especially the pancreas and/or splenic artery.
- •d. Gastric resection/mobilisation surgery with surgical access of the lesser
- •e. Celiac axis, aneurysms or anatomy associated with congenital anomalies of
- •the origin of the splenic artery.
- •f. 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.
- •g. Participants who do not have a demonstrable clear plane between the pancreas
- •and the splenic artery, at the interface site, in the preoperative CT angiogram.
- •h. Findings of cirrhosis or portal hypertension.
- •i. Documented history of pancreatitis with significant peripancreatic
- •inflammation (CT evidence of necrosis, pseudocyst formation or significant
- •retroperitoneal calcification).
- •j. Pancreatic abnormalities/mass/cyst/pseudocyst/lesions.
- •k. Any condition per the investigator's clinical judgment that qualifies the
- •participant not fit for surgery.
- •l. BMI >= 33.
研究者
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