Autoimmune Rheumatic Diseases

This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy. Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening. Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes. The main questions this study aims to answer are: Does continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients. Participants will: Be randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals. The study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and/or genital) before inclusion.

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether single-dose amoxicillin prophylaxis administered prior to simple tooth extraction reduces postoperative infection rates inpatients with autoimmune rheumatic diseases (ARDs). Although antibiotic prophylaxis is not recommended for healthy individuals undergoing simple extractions, immunosuppressed ARD patients frequently receive antibiotics despite limited evidence supporting this practice. Secondary objectives include assessing infection severity, postoperative complications, and the impact of ARD diagnosis and immunosuppressive treatment on infection risk.

This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs). Key questions: * Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity? * What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity? * What is the risk of disease flaring with MTX withdrawal?

This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.