Status:
COMPLETED
Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
SetPoint Medical Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis wh...
Detailed Description
This is a two-stage study where Stage 1 is open label, and Stage 2 is randomized and sham controlled where the sites and subjects are blinded to treatment. Three subjects will be enrolled in Stage 1 o...
Eligibility Criteria
Inclusion
- Male or female and 22-75 years of age, inclusive
- Have provided informed consent
- Have a diagnosis of adult-onset rheumatoid arthritis as defined by the 2010 ACR/EULAR classification criteria (Aletaha, 2010)
- Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints and CDAI score \>10
- Have been treated at approved doses with at least 2 biologic DMARDs and/or new targeted synthetic DMARDs (e.g. JAK inhibition) for at least 3 months and either:
- experienced insufficient efficacy or loss of efficacy
- experienced intolerance of such treatment
- Have had regular use of at least 1 conventional DMARDs for at least the 12 weeks prior to study entry with a continuous, non-changing dose for at least 8 weeks prior to screening visit
- Women of childbearing potential must not be pregnant at the time of screening and must agree to use a double barrier method of contraception throughout the study
Exclusion
- Have taken the following within the defined time period prior to screening visit:
- i. Rituximab: 6 months ii. Infliximab, golimumab, adalimumab, certolizumab pegol, tocilizumab: 60 days iii. Abatacept, etanercept, anakinra: 30 days iv. Tofacitinib: 30 days v. Investigational biologic agents: 6 months for depleting agents, 60 days for others vi. Investigational small molecules: 5 times the pharmacokinetic half-life or 30 days, whichever is longer vii. Intra-articular corticosteroid injection: 30 days
- Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of screening visit
- Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of screening visit
- Documented significant psychiatric illness or substance abuse
- Active infection requiring treatment with antibiotics
- Uncontrolled hypertension
- Uncontrolled diabetes
- History of stroke
- Known cardiac disease, including cardiomyopathy with ejection fraction \<40%, recent myocardial infarction or unstable angina, or heart failure with New York Heart Association class III or IV symptoms
- Known neurological syndromes
- Known atherosclerotic disease including contralateral carotid artery
- BMI \<18.5 or \>35
- Any condition per the investigator's clinical judgment that precludes participation in the study
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03437473
Start Date
March 6 2018
End Date
December 10 2018
Last Update
December 27 2018
Active Locations (4)
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1
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
2
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
3
Northwell Health Division of Rheumatology
Great Neck, New York, United States, 11021
4
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635