RecruitingRecruiting
Safety of Splenic Stimulation for RA
NCT04955899 · Galvani Bioelectronics
In plain English
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Official title
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
About this study
The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.
Eligibility criteria
Inclusion Criteria:
* Adult-onset RA of at least six months duration
* Male or female participants, 22-75 years of age
* Active RA
* Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
* Have an appropriate washout from previously used biological DMARDs or JAKi
* A female participant should have no child-bearing potential
Exclusion Criteria:
* Inability to provide informed consent.
* Significant psychiatric disease or substance abuse.
* History of unilateral or bilateral vagotomy.
* Active or latent tuberculosis
* Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B.
* Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
* Previous splenectomy
* Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
* Uncontrolled other inflammatory diseases
* Current/recurrent infections that in the opinion of the PI risk\>benefit.
* History of cancer within the past 5 years, except non-malignant skin cancer.
* Chronic use of morphine or oxicodone
Study design
Enrollment target: 5 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-10-20
Estimated completion: 2029-04
Last updated: 2024-02-14
Interventions
Device: Active Stimulation
Primary outcomes
- • Safety and tolerability of the Galvani system (12 weeks)
Sponsor
Galvani Bioelectronics · industry
With: NAMSA
Contacts & investigators
ContactOperations Director · contact · clinical@galvani.bio · +44 (0)800 3688514
All locations (2)
Academic Medical Center (AMC) Dept of Rheumatology & Clinical ImmunologyRecruiting
Amsterdam, Netherlands
Greater Glasgow Health BoardRecruiting
Glasgow, United Kingdom