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Showing 1-20 of 32 trials
NCT06647069
This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.
NCT07484243
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.
NCT07268326
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity. The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in: \- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life. The effects of the PBD will be compared to a habitual diet, that includes no dietary changes. Participants in the intervention group will: * Receive weekly delivery of food boxes which include plant-based food items * Receive a daily multivitamin supplement * Receive continuous dietetic guidance * Participate in a practical cooking class to get an introduction to a PBD * Participate in three online supervisions throughout the intervention period Participants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.
NCT07435272
Objectives: Impairment of physical function is a core feature of RA, particularly in patients with high disease activity where pain and inflammation directly limit movement. but, Reduced mobility in RA is not exclusively driven by inflammatory pathology. There are non-inflammatory factors, including kinesiophobia, fatigue, depression, and anxiety, may significantly contribute to functional limitation and may initiate a self-perpetuating cycle in which movement avoidance leads to physical deconditioning, muscle weakness, and progressive functional decline. The aim of this study is to examine the relationship between kinesiophobia and functional outcomes in patients with rheumatoid arthritis, and to investigate its associations with disease activity, pain, fatigue, depressive symptoms, anxiety, and sarcopenia, with a focus on factors relevant to functional assessment and rehabilitation. Patients and Methods A case - control study will be conducted on Two hundred adult patients previously diagnosed with RA according to ACR/EULAR 2010 criteria for RA and 200 apparently healthy volunteers with age and sex matching will be involved in the study. The study will be conducted in Rheumatology department, Minia university Hospital, Egypt. All patients will be subjected to history taking, clinical examination, and assessment of the following parameters: 1. Kinesiophobia: using the Arabic version of TSK-17 2. Disease activity: using DAS 28 3. pain severity using the Visual Analogue Scale (VAS) 4. Fatigue: using the Arabic version of the Fatigue Severity Scale (FSS) 5. Depression: using the Arabic version of the BDI-2 6. Anxiety: using the Arabic version of the BAI 7. sarcopenia using the Arabic version of the SARC-F questionnaire 8. Functional disability: using the Arabic version of the HAQ-DI 9. Physical activity:using IPAQ-SF
NCT07416656
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)?
NCT07367438
The study will include 2 groups. The study group will receive subthreshold stimulation, while the control group will receive sham treatment.
NCT06991114
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.
NCT07264101
This cross-sectional observational study aims to evaluate the validity and reliability of the Four Square Step Test (FSST) in individuals with rheumatoid arthritis. In addition, the study will investigate the associations between FSST performance and clinical parameters including disease activity, quality of life, pain, and muscle strength. All assessments will be conducted according to a pre-defined standardized protocol. The order of measurement tools will be randomized to minimize potential bias, and sufficient rest intervals will be provided between tests to prevent fatigue and performance effects. Participants will include individuals aged 18-65 years with a diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 classification criteria, who have been followed for at least 6 months, have had no major changes in treatment regimen in the last 4 weeks (e.g., initiation or change of DMARDs/biologics, high-dose steroid increase), can walk at least 10 meters independently, have a Mini-Mental State Examination score of 24 or higher, and are able to follow verbal instructions in Turkish to comply with study procedures. Appropriate statistical methods will be applied to assess validity, reliability, and associations between FSST and clinical parameters.
NCT06628206
The goal of this clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.
NCT07056608
Cardiovascular diseases (CVD) are still the most common cause of death. For these reasons, individuals, especially those with chronic diseases, need to be aware of CVD. CVD is also a significant cause of morbidity and mortality in rheumatoid arthritis (RA). This study aimed to compare CVD awareness in RA and knee osteoarthritis (KOA).
NCT06671054
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
NCT06876064
PROMESS 1 is a multicenter cohort interventional study aiming at analyzing the factors associated with the risk of developing clinical arthritis among exposures or combinations of exposures in patients at risk of rheumatoid arthritis (RA), as they have high levels of anti-citrullinated peptides autoantibodies (ACPA ≥2 N). The primary endpoint is the occurrence of clinical arthritis confirmed by ultrasound at two years of following for the subject's groups at risk of RA. This may be explained by the following exposures or combinations of exposures: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress. Other factors may also explain the occurrence of clinical arthritis: * Other symptoms * Comorbidities, medical history, drug exposures * Current biology: ACPA levels, rheumatoid factor levels and isotypes, CRP levels at baseline, etc. * Ultrasound and MRI abnormalities.
NCT06888960
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy. CC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the "biopharmaceutical version" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy. The study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A "3+3" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.
NCT07147127
1. To measure serum level of anticitrullinated SR-A peptide antibody (anti-CSP) in RA patients compared to healthy controls . 2. To assess the diagnostic performance of anti-CSP for RA specifically seronegative RA patients. 3. To evaluate correlation of serum anti-CSP level with disease activity and functional disability scores in RA patients.
NCT07141927
This is a cross-sectional study aimed at examining the effects of kinesiophobia and proprioception on disability and function in the rheumatoid hand, compared to healthy controls.
NCT07123038
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
NCT07013110
This clinical study is a multi-center, randomized, double-blind, placebo-controlled, outpatient study comparing the efficacy of combination of dnaJP1 peptide and hydroxychloroquine versus combination of placebo and hydroxychloroquine in patients with moderately to severely active RA who are naive to cs-, b-, tsp.-DMARDs. A sample size of 124 patients will be enrolled in the study. Each patient will receive either combination of dnaJP1 peptide and hydroxychloroquine or combination of placebo and hydroxychloroquine in 1:1 allocation ratio.
NCT06933134
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.
NCT07085676
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.
NCT07069088
This study aims to characterize and compare patients of adult-onset RA with patients of elderly-onset RA based on the clinical manifestations, disease activity, severity parameters, and therapeutic features.