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
- Conditions
- Rheumatoid arthritisArthritis1000381610023213
- Registration Number
- NL-OMON55923
- Lead Sponsor
- Galvani Bioelectronics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 4
* 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
the IC.
* 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
Day 1.
* Any prior investigational treatment must be discontinued for 2 weeks or 2
half-lives, whichever is longer, prior to surgery.
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
screening
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective and associated endpoints for Period 1 en 2 of this study<br /><br>are:<br /><br>Evaluating the safety and tolerability of the Galvani spleen neuromodulation<br /><br>system and stimulation of the splenic nerve as assessed by:<br /><br>a. Incidence, causality, and severity of adverse reactions (AEs), serious<br /><br>adverse reactions (SAEs), adverse reactions to devices (ADEs) and serious side<br /><br>effects of devices (SADEs).<br /><br>b. Laboratory safety assessments (clinical chemistry and haematology).<br /><br>c. Vital signs measurements (blood pressure, heart rate, respiratory rate and<br /><br>body temperature).<br /><br>d. 12-Lead ECG monitoring.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Effect of stimulation on the change in pharmacodynamic and response<br /><br>biomarkers:<br /><br>Changes from baseline (Day 1) in the levels of LPS-inducible cytokine/<br /><br>chemokine release, in whole blood assay at different timepoints after start of<br /><br>stimulation<br /><br><br /><br>2. To evaluate the usability of the external Galvani System devices and<br /><br>accessories:<br /><br>Summarize feedback collected on questionnaires on the use of the external<br /><br>Galvani System devices<br /><br><br /><br>3.To evaluate the participants' perception of therapy and sensation:<br /><br>Summarize feedback collected on questionnaires<br /><br><br /><br>4. Evaluate device performance:<br /><br>Tabulation of device deficiencies</p><br>