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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT06361199 Completed - Clinical trials for Rheumatoid Arthritis

Proximod Pharmacokinetics in Healthy Subjects and Patients With Rheumatoid Arthritis

Start date: December 16, 2021
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects and patients with rheumatoid arthritis. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Proximod in health subjects after repeated doses. 2. to assess the pharmacokinetics and pharmacodynamics of Proximod in healthy subjects after repeated doses. 3. to evaluate the safety and tolerance of Proximod in patients with rheumatoid arthritis. 4. to evaluate the pharmacokinetics and pharmacodynamics of Proximod in patients with rheumatoid arthritis. Participants will receive test tablets or placebo at the indicated date and collect blood samples.

NCT ID: NCT06361186 Completed - Clinical trials for Rheumatoid Arthritis

Proximod Pharmacokinetics In Healthy Subjects

Start date: September 14, 2017
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the tolerability, pharmacokinetics and pharmacodynamics of Proximod in healthy subjects. The main questions it arms to answer are: 1. to evaluate the safety and tolerance of Proximod in healthy subjects after single or repeated doses. 2. to learn the pharmacodynamics of Proximod in healthy subjects after single or repeated doses. 3. to evaluation of the effect of food on the pharmacokinetics of Proximod in healthy subjects Participants will receive test tablets or placebo at the indicated date and collect blood samples.

NCT ID: NCT06341348 Completed - Clinical trials for Rheumatoid Arthritis

Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients. A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation. This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them.

NCT ID: NCT06337786 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis

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

Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability. There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease. The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual. The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA

NCT ID: NCT06337370 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Self-management Nursing Intervention for Women With Rheumatoid Arthritis

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

Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the QOLRA-II; self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care.

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.