Clinical Research Directory

COMFI - a COMbined Fatigue Intervention

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.

Mass Spectrometry-based Immune Profiling in Autoimmune Diseases

Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.

Predictors of Cardiac Arrhythmia in Rheumatoid Arthritis Patients

To evaluate QT dispersion, P-wave dispersion and Tp-e dispersion as predictors of cardiac arrhythmias in patients with rheumatoid arthritis and to assess their relationship with disease characteristics and inflammatory activity

Controlling Hyperactive Immunity With Long-lived Lymphocytes

This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms. QEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion. To take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic. Throughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1/2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.

Nutrition in Rheumatoid Arthritis

Background: Individuals with Rheumatoid Arthritis (RA) often experience persistent symptoms such as pain and stiffness despite modern pharmacological treatments. They also have an increased risk of cardiovascular disease. Elevated risk factors for cardiovascular disease limit the options for symptom-relieving medications, making a reduction in these risk factors highly desirable. Diet has been shown to reduce several of these factors, but the scientific evidence for rheumatoid arthritis is limited, and thus tailored dietary advice is lacking. Objective: The purpose of the NUTRA study is to evaluate the effect of a diet that follows the updated Nordic Nutrition Recommendations (2023) on disease activity and cardiovascular risk factors in individuals with newly diagnosed RA. Specifically, the study will analyze the impact of the diet on clinically relevant markers such as blood pressure, lipid profile, inflammatory markers, and body composition. Study Plan: The study will include about 150 patients, and participants will follow a standardized care protocol where, at their three-month visit, they are randomized into either a diet following the Nordic Nutrition recommendations or a Nutrient rich diet. The intervention diets, will be added as a complementary treatment to the medications the patients are already taking. Participants will receive menus, recipes and some foods for three months, followed by self-maintenance of the diet. Clinical markers will be evaluated before the intervention as well as at three and nine months. Artificial intelligence will be used to predict which factors are crucial for achieving the best possible outcomes from dietary treatment. Significance: The NUTRA study is highly significant as it aims to generate evidence to guide the design of dietary interventions for patients with rheumatoid arthritis. By understanding the potential role of diet in reducing both disease activity and cardiovascular risk, the study may contribute to improved treatment strategies for this challenging patient group.

Twenty-four Hour Movement Behaviors and Atherosclerotic Risk

This observational study aims to investigate how 24-hour movement behaviors are associated with atherosclerotic risk in adults with rheumatoid arthritis. These behaviors include physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Are 24-hour movement behaviors, both individually and in combination, associated with indicators of atherosclerotic risk in adults with RA? * Do changes in 24-hour movement behaviors over 12 months relate to changes in indicators of atherosclerotic risk? Participants will: * Wear activity monitors (accelerometers) continuously for 7 days to measure physical activity, sedentary behavior, and sleep. * Answer questionnaires about their health and lifestyle. * Undergo cardiovascular assessments, body composition measurements, physical fitness tests, and blood tests to measure lipid and inflammatory profile. * Return 12 months later for follow-up assessments. The researchers hope this study will improve understanding of how daily movement behaviors influence cardiovascular health in people with rheumatoid arthritis. The findings may help inform future recommendations to promote healthier movement behaviors and improve cardiovascular risk management in this population.

Self-Care Education for Joint Stiffness and Functional Ability in Rheumatoid Arthritis

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that may cause joint stiffness, pain, reduced mobility, and impaired functional ability. Self-care education may help patients improve their knowledge and practices related to disease management, joint protection, physical activity, exercise, energy conservation, and symptom management. This study aims to evaluate the effectiveness of a self-care educational program on joint stiffness and functional ability among patients with rheumatoid arthritis. Participants will be assigned to either a study group or a control group. The study group will receive the self-care educational program in addition to routine care, while the control group will receive routine care only. Joint stiffness and functional ability will be assessed before and after implementation of the educational program.

A First-in-human Study of KT502 in Adult Participants With Rheumatoid Arthritis (RA)

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.

A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.

TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs

This is a randomized, double-blind, placebo-controlled parallel-group Phase II study. The study aims to evaluate the efficacy and safety of TLL-018 in adult patients with moderate to severe active rheumatoid arthritis who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Clinical Study Comparing Diosmin vs Rebamipide as Adjuvant Therapies vs Conventional Therapy in Patients With Rheumatoid Arthritis

This study will be a randomized controlled parallel study that will be conducted on 66 patients with active rheumatoid arthritis who will be diagnosed with RA according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR, 2010). The patients will be recruited from Outpatient Clinic of Rheumatology, Physical Medicine, Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. The study duration will be 3 months. The patients will be randomized into three groups: \- Group 1 (control group): will include 22 patients who will receive the conventional therapy for RA for 3 months. \- Group 2 (diosmin group): will include 22 patients who will receive the conventional therapy for RA plus 1000 mg diosmin once daily for 3 months. \- Group 3 (rebamipide group): will include 22 patients who will receive the conventional therapy for RA plus 100 mg rebamipide three times daily for 3 months.

Inflammatory Arthritis and Tango

The hypothesis is that pleasure brought by argentine tango practice would increase total physical activity of patients with chronic inflammatory arthritis.

Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis

The goal of this clinical trial is to learn if optimised protein intake improves household work capacity and overall functional status in women with rheumatoid arthritis. It will also assess the safety and tolerability of dietary protein supplementation. The main questions it aims to answer are: Does optimised protein intake reduce household work limitations measured by the Household Work Limitations Questionnaire (HOWL-Q)? Does optimised protein intake improve overall functional disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)? What side effects or tolerability issues do participants experience with dietary protein modification and supplementation? Researchers compared participants receiving structured dietary counselling and protein supplementation (targeting 1.0 g/kg/day) to their baseline protein intake to determine if the intervention improves functional outcomes in women with stable rheumatoid arthritis on disease-modifying antirheumatic drugs.

BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.

Integrated Clinical Study of Traditional Chinese and Western Medicine for Refractory Rheumatoid Arthritis

To evaluate the efficacy and safety of Kunxian Capsule combined with Methotrexate and Tofacitinib in the treatment of difficult-to-treat rheumatoid arthritis through a multicenter, randomized, double-blind, placebo-controlled clinical trial, and to identify the therapeutic advantages of integrated Chinese and Western medicine for optimizing the clinical strategy of D2T RA.

The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis

The goal of treating patients diagnosed with rheumatoid arthritis (RA) is to achieve remission or low disease activity and thereby prevent joint damage, loss of physical function, and disability. Optimal management requires regular assessment of disease activity, with treatment changes made as needed for optimal efficacy. Vectra is a blood serum test that looks at 12 biomarkers and produces a score on a scale of 1 to 100. The Vectra score has been shown to be the strongest predictor of risk for progression of disease. There is opportunity to gain more information about the utility of Vectra in a real-world clinical setting. This study will, therefore, evaluate the utility of Vectra for guiding treatment decisions and improving RA-related outcomes in comparison with usual care, which will not include Vectra testing. This study will enable a direct evaluation of the clinical benefit associated with using Vectra to guide treatment decisions in patients with RA.

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

This is a large-scale, multicenter observational study on the treatment of rheumatoid arthritis (RA) with integrated Traditional Chinese and Western medicine. The study plans to enroll at least 10,000 patients, including a minimum of 1,000 cases with difficult-to-treat RA (D2T RA) and 1,000 cases with RA-associated interstitial lung disease (RA-ILD). Through long-term follow-up, data will be collected on Traditional Chinese Medicine (TCM) syndrome characteristics, treatment plans, adverse drug reactions, and complications. Biological samples, including blood and urine, will also be collected. The research will utilize multi-omics technologies such as genomics and proteomics, combined with clinical data, to deeply explore the modern scientific connotation of the "disease-syndrome-symptom" framework in RA. The goal is to clarify the patterns and advantages of TCM syndrome differentiation and treatment. Based on these findings, a scientific and standardized efficacy evaluation system for integrated treatment will be established, and optimized treatment strategies for D2T RA and RA-ILD will be developed. The project is led by multiple national TCM clinical research centers and regional diagnostic and treatment centers, including the First Teaching Hospital of Tianjin University of TCM and Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine. These institutions have mature clinical research platforms, biobanks, and databases, providing a solid foundation for the successful implementation of this study. The results of this research will provide a scientific basis for the integrated treatment of RA, promote the standardization of diagnostic and treatment protocols, and ultimately improve the overall level of RA prevention and treatment in China.

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases

The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age. The main questions it aims to answer are: Does the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs? Researchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles. All participants will: * receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection; * undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses; * attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests; * report any symptoms or adverse events using a standardized diary for 42 days; * be followed for up to one year for long-term safety and immunogenicity assessments. * wear a device for 14 consecutive days to assess current and habitual physical activity levels. * answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status. * collect blood samples one-year after vaccination to access immunogenicity and cellular response. Researcher will also perform subgroups analysis in: A viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration. An immunogenicity subgroup (\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.

the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients

this study aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI

Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological Therapy

This study aims to evaluate a new tool designed to help doctors decide whether it is safe to reduce medication in patients with rheumatoid arthritis (RA) who are in remission. Rheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing pain, stiffness, and reduced mobility. Many patients receive long-term treatment with biological drugs to control the disease. When the disease is well controlled (remission), doctors may gradually reduce the medication dose. However, deciding when and in whom to reduce treatment is currently based on experience and trial-and-error. The study evaluates a predictive tool (called OPTIBIO) that uses information from blood samples, genetic data, and clinical characteristics to estimate the risk that the disease will flare up if treatment is reduced. Participants in the study will be randomly assigned to one of two groups: * In one group, the decision to reduce medication will be made by their usual doctor. * In the other group, the decision will be guided by the predictive tool. The study lasts 12 months and includes several hospital visits. During these visits, participants will: * Answer questionnaires about their health and quality of life * Have physical examinations * Provide blood samples for routine tests and additional research purposes * Possibly undergo joint ultrasound (if they consent) Some additional blood samples may be stored in authorized biobanks for future research related to rheumatoid arthritis, but only if participants explicitly agree. These samples will be coded to protect personal identity and will only be used in ethically approved research projects. Participation in the study is entirely voluntary. Participants can choose which procedures they agree to and may withdraw at any time without affecting their medical care. The study may not provide direct benefit to participants, but it could help improve future treatment decisions and the overall management of rheumatoid arthritis.

Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis

The aim of this study is to offer patients two treatment options: morning or evening administration of a JAK inhibitor prescribed within the framework of its marketing authorization, according to the EULAR response. The objective is to determine whether evening administration in our patients with rheumatoid arthritis provides greater efficacy than morning administration in our patients taking JAK inhibitors once daily.

Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine

The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels. This may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values. The study aims to answer two main questions: 1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold? 2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol/mol)?

Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis

The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Does an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical/psychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs? Researchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention. Participants in the experimental group will: Use a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period. Complete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.

A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis

The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.