Clinical Research Directory

Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care

Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. It is a heterogeneous disease, whose complexity is only partially encompassed by the actual classification criteria and it is characterized by prolonged synovial inflammation that can lead to joint destruction. Whilst the assessment of structural joint damage is part of the routinary evaluation of disease severity and progression in patients with rheumatoid arthritis (RA), to the extent that it is considered a key end-point outcome in treatment efficacy studies, this is not the same for JIA. Some recommendations have been elaborated based on expert opinion, but only recently they have been translated into clinical practice. Such a discrepancy in approaching chronic arthritis has been for many years due to the lack of articular damage radiographic scoring system validated for pediatric age. Actually, joint space narrowing, bone erosions and demineralization, which is typical of adult articular damage, are not the same changes observed in pediatric population where early growth plate closure, epiphyseal deformity and growth asymmetries can be the major signs. The transition process from the pediatric to the adult health care team is a critical moment in the clinical history of patients with JIA, often hampered by the absence of specific criteria for the assessment of disease activity, the lack of specific treatment recommendations for JIA adult patients, the poor adolescent-specific training for adult rheumatologists, and the lack of communication between pediatric and adult centers. Adult patients with JIA have their own specific identity and should not be inappropriately re-categorized as having RA, ankylosing spondylitis or another condition once transitioned to the adult rheumatologist. The aim of this study is to quantify the articular damage of adult patient with JIA after closure of growth plates. This represent a sort of starting burden carried by the patients who receive transition to the adult rheumatologist care and which should be minimized in order to reduce long-term complications. Furthermore, the study aims to analyze possible correlations between the presence of articular damage, therapies taken in pediatric age, and characteristics of JIA at the onset and during the clinical course of the disease

Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

The purpose of HZ-REUMA study is explore vaccine response and protection against shingles (herpes zoster, HZ) after vaccination with two doses of Shingrix in immunosuppressed patients with inflammatory rheumatic diseases (IRD) compared to immunocompetent patients with IRD (controls). Hypothesis: The immunological disturbance as part of the rheumatic disease in combination with different immunomodulating treatments may impair vaccine response to non-live HZ vaccine (Shingrix) and thereby lead to an insufficient protection against infection. Primary objective (outcome) 1. The impact of modern anti-rheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, anti-INFERON treatment, or targeted DMARDs (JAK-inhibitors) on antibody response elicited by two doses of subunit vaccine against herpes zoster (HZ) administrated 1-2 months apart in patients with IRD. Secondary outcomes 2. The numbers and frequency of antigen specific CD4 2+ T cells expressing ≥2 or more activation markers (TNFalpha, INF-gama, interleukin-2 or CD40ligand) 3. Long-term immunogenicity of two doses of Shingrix in immunosuppressed patients with IRD measured 3 and 5 after vaccination 4. the tolerability of the vaccine, the impact on existing rheumatic disease, and possible association with onset of new autoimmune diseases 5. if vaccination against herpes zoster protects against infections in patients with inflammatory rheumatic diseases Study Population Adult patients (18 years and older) with a clinically diagnosed inflammatory rheumatic disease and regularly followed at Skåne University Hospital, section for rheumatology in Lund/Malmö, Sweden are eligible for the study and will be offered vaccination free of charge. Control group comprises adult individuals with known inflammatory rheumatic disease without immunosuppressive treatment except for low dose prednisone (max 5 mg daily) . Inclusion criteria: * age ≥18 years (patients) * regular follow up at Skåne University Hospital, section for rheumatology Lund/Malmö due to an inflammatory rheumatic disease (patients) * receive active treatment with disease modifying anti-rheumatic drugs (DMARDs) such conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARDs or patients without active immunosuppressive treatment (controls) Exclusions criteria * age \<18 years (patients) * pregnancy (women of childbearing potential, WOCBP, are not excluded since all patients using DMARDs are advised to use a safe and effective contraceptive method) * allergy/intolerability of any component in the vaccine * active infection inclusive herpes zoster (shingles) * received Shingrix vaccine previously * ongoing treatment with any immunosuppressive drug for the other diseases Target enrolment/sample size: 240. Study start date: December, 17 2024- June 30, 2029