Tests a nerve-stimulating ear device in rheumatoid arthritis
Tests an ear device that stimulates a nerve, in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study
Key facts
- Where
- Lund, Malmö, Örebro, Stockholm, and Umeå, SwedenSee the 6 sites
Where in Sweden
- Section for Rheumatology, Skåne University Hospital, LundLund, SwedenTaking people
- Section for Rheumatology, Skåne University Hospital, MalmöMalmö, SwedenTaking people
- Dept of Rheumatology, Örebro University HospitalÖrebro, SwedenTaking people
- Center for Rheumatology, Academic Specialist CentreStockholm, SwedenTaking people
- Karolinska University HospitalStockholm, SwedenTaking people
- Dept of Rheumatology, Umeå University HospitalUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- taVNS AB
- Trial code
- NCT06779123
- Record updated
- 10 September 2025
- Original description
Purpose and aimRead full original descriptionShow less
Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis
Purpose and aim
The overall aim is to investigate efficacy and safety of a newly developed non-invasive auricular investigational device that electrically stimulates the auricular branch of the vagus nerve to activate the cholinergic anti-inflammatory mechanism to treat rheumatoid arthritis patients not responding to standard therapy. The mode of treatment is termed transcutaneous auricular vagus nerve stimulation (taVNS). Specifically, the investigators will address the following research questions:
The investigation is a multicenter, placebo-controlled, randomized, double-blinded, superiority, clinical study to evaluate the safety and efficacy of a novel transcutaneous auricular vagus nerve stimulator system, termed TRAVAGUS, in patients with moderate-to-severe rheu-matoid arthritis (RA) who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs). The primary efficacy endpoint is the proportion of patients achieving an ACR20 response (a composite measure of the effectiveness of arthritis treatments set forth by the American College of Rheumatology) in the treatment group compared to sham group at 12 weeks. Electrical vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. RA is a global disease associated with significant reduced quality of life and very high health care costs substantially driven by therapeutics. While many with RA have benefited from modern era biologic and small molecule therapies, unresolved chronic inflammation is common despite treatment. Therefore, non-toxic, lower cost anti-inflammatory, non-pharmacologic therapy is needed.
Note: This study relates to a FDA-nonregulated Drug and FDA-nonregulated Device. There are no U.S. Locations for the study. The study was approved by EMA.
Inclusion: > 18 years of age on day of signing informed consent; Active RA, DAS28>3.2, at least 4/28 tender and 4/28 swollen joints; Demonstrated an inadequate response, loss of response, or intolerance to one or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors; Stable dose of glucocorticoids or conventional disease-modifying agents in RA (csDMARDs) at least 2 and 4 weeks, respectively, before screening.
Exclusion: History of vagotomy; Untreated or poorly controlled psychiatric illness; Significant immunodeficiency due to underlying illness; History of cerebrovascular insult; Clinically significant cardiovascular disease; Partial or complete splenectomy; Recurrent vasovagal syncope episodes; Uncontrolled fibromyalgia; Pregnancy (if sexually active, using reliable form of birth control or being at least 2 yrs post-menopausal).