Treatment With Auricular Vagus Nerve Stimulation in Rheumatoid Arthritis - the TRAVAGA Study

Recruiting now · Not applicable

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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.

Key facts

Study ID: NCT06779123
Run by: taVNS AB
People needed: 128
Starts: 2025-03-21
Expected to finish: 2027-06-15
Last updated by the study team: 2025-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

> 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

You may not qualify if…

History of vagotomy
Partial or complete splenectomy
Recurrent vasovagal syncope episodes
Untreated or poorly controlled psychiatric illness
Significant immunodeficiency due to underlying illness
History of cerebrovascular insult
Clinically significant cardiovascular disease
Uncontrolled fibromyalgia
Pregnancy (if sexually active, using reliable form of birth control or being at least 2 yrs post-menopausal)

Where it is running

Section for Rheumatology, Skåne University Hospital, Lund — Lund, Skåne County, Sweden (enrolling)
Section for Rheumatology, Skåne University Hospital, Malmö — Malmö, Sweden (enrolling)
Dept of Rheumatology, Örebro University Hospital — Örebro, Sweden (enrolling)
Center for Rheumatology, Academic Specialist Centre — Stockholm, Sweden (enrolling)
Karolinska University Hospital — Stockholm, Sweden (enrolling)
Dept of Rheumatology, Umeå University Hospital — Umeå, Sweden (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.