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

RecruitingNAAges 18 Years - anyAlltaVNS AB
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In plain words

What the trial is, and whether it could suit you

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 modifyi

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * \> 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 Criteria: * 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)
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What it tests

  • Transauricular vagus nerve stimulation.
  • transauricular vagus nerve non-stimulation
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Where

6 sites
Section for Rheumatology, Skåne University Hospital, Lund
Lund, Sweden
Section for Rheumatology, Skåne University Hospital, Malmö
Malmö, Sweden
Dept of Rheumatology, Örebro University Hospital
Örebro, Sweden
Center for Rheumatology, Academic Specialist Centre
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Dept of Rheumatology, Umeå University Hospital
Umeå, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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