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Arthritis clinical trials

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NCT ID: NCT06322784 Completed - Clinical trials for Rheumatoid Arthritis

DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are: - To verify the effect of dietary fiber supplementation on reducing the level of inflammation; - To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis. The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made

NCT ID: NCT06309030 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs.

NCT ID: NCT06306339 Not yet recruiting - Clinical trials for Moderate to Severe Rheumatoid Arthritis

A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)

Start date: March 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA).

NCT ID: NCT06305936 Recruiting - Clinical trials for Rheumatoid Arthritis

Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis

PLATE
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention. Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible.

NCT ID: NCT06305026 Recruiting - Clinical trials for Rheumatoid Arthritis

Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia

Start date: February 7, 2024
Phase:
Study type: Observational

Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM. Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria). Data collection: Will be done as study subjects are included and stored in REDCAP. Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests. Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series. Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia. Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test.

NCT ID: NCT06301958 Recruiting - Arthritis Knee Clinical Trials

Dextrose Prolotherapy on Articular Cartilage

Start date: January 21, 2023
Phase: N/A
Study type: Interventional

Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid. We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.

NCT ID: NCT06301373 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.

NCT ID: NCT06299917 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

WORK-ON Vocational Rehabilitation

WORK-ON
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues. Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.

NCT ID: NCT06297694 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis

Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis.

NCT ID: NCT06295848 Recruiting - Hypertension Clinical Trials

The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients

CARDIRA
Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment. Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program.