ConsideRAte Study - Splenic Stimulation for RA
Recruiting
N/A
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 22 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 28 (estimated)
- Sponsor
- Galvani Bioelectronics · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* RA of at least six months duration, per 2010 ACR/EULAR criteria
* Male or female participants, 22-75 years of age
* Active RA
* Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
* Have an appropriate washout fr…
Contacts