Rheumatoid arthritis clinical trials — recruiting now

Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.

The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.

Chronic peripherial arthritides are common diseases with soaring public health consequences. Our goal is to assess the role of photon-counting detector computed tomography in the diagnostics of peripherial arthropathies.

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.

Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and/or impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation. The primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline. This study will show if the intervention is feasible in practice and meaningful for the participants.

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome

The goal of this clinical trial is to learn if increasing dietary fiber can improve the gut microbiome and reduce disease activity in adults with rheumatoid arthritis (RA). The main questions it aims to answer are: * Can a higher fiber diet improve gut bacteria and produce beneficial short-chain fatty acids (SCFAs)? * Does a higher fiber diet reduce RA symptoms and help with weight loss? Researchers will compare two groups: one group will receive dietary counseling and take 10 grams of psyllium husk daily, while the other group will continue their usual diet. Participants will: * Complete dietary questionnaires at the start, 6 months, and 12 months. * Provide stool samples for gut bacteria and SCFA analysis. * Have their RA activity and body weight monitored regularly. * Receive regular phone calls to support the dietary changes. The study will involve adults with diagnosed RA who can provide informed consent and meet other inclusion criteria.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.

Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).

The purpose of this study is to determine the safety and tolerability of plamotamab in patients with rheumatoid arthritis. Participants will be given XmAb13676 subcutaneously (SC) by injection under the skin.

Design: A prospective, single-arm, multicenter, real-world study that does not interfere with the patient's treatment plan Primary Objective: 1\. To evaluate the effectiveness and safety of subcutaneous Methotrexate (MTX) in RA patients in a real-world setting; Exploratory Objectives: 1. To assess the safety and effectiveness of subcutaneous MTX in RA patients with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs), and stable coronary artery disease (SCAD) in a real-world setting; 2. To evaluate the effectiveness and safety of subcutaneous MTX in RA patients with different clinical subtypes. The study includes adult RA patients treated with subcutaneous MTX, divided into the following four cohorts based on comorbidities and clinical subtypes: Cohort 1: Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) Cohort 2: Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) Cohort 3: Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) Cohort 4: Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases)

1. Patients taking leflunomide as the only disease-modifying anti-rheumatic drug (DMARD) will be recruited after consent. 2. Blood sample for DNA extraction will be taken The patient will be followed up till two visits 3 months apart, and efficacy and toxicity will be checked using DAS28, ultrasonography, and blood tests for ESR, CRP, anti-CCP, liver function tests, etc. The data form for toxicity will be filled. 3. DNA will be extracted in the laboratory, and SNP will be identified. 4. The efficacy and toxicity data will be studied against the SNPs found 5. An algorithm will be constructed for Pakistani RA patients taking leflunomide.

The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs. Despite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation. The assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy. Through this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.

SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis" RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same.

Purpose: The study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients. Study Design: This is a single-center, prospective randomized study.

The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance. Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.

The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Rheumatoid Arthritis. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Rheumatoid Arthritis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.