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NCT ID: NCT06417138 Recruiting - Clinical trials for Rheumatoid Arthritis RA

"Comparative Effect of Different Drugs Used to Tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)"

Start date: December 15, 2023
Phase:
Study type: Observational

Comparative effectiveness of different drugs used to treat patients in Rheumatoid Arthritis Saudi database (RASD) Introduction Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3). In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag time from the onset of symptoms until the initiation of treatment in patients with RA has been collectively calculated to be around almost one year time (5). Diseases modifying anti rheumatic agents (DMARDS) are the main drugs used for the management of RA, and it mainly reduce the inflammation and improve the outcomes(6). Several DMARSs drugs are available for the management of RA, however, recently, biological DMARDS have also been widely used and recommended in case the conventional DMARDS fail to control the diseases(6,7). Worldwide, there have been multiple studies that examined the effectiveness of DMARDS and bDMARDS drugs for the management of RA, this include large controlled trials which are the gold standard method for investigating medications efficacy(8,9). However, observational real-world data to examine the effectiveness of these medications is also important and can be more generalizable, have longer follow up and can examine different characteristics. Previous observational studies investigating the effectiveness of DMARDS and bDMARDS were mainly in Europe and North America which does not necessarily represent the current situation and the characteristics of the middle eastern population(10,11), as there is so much variability in access to different biological drugs in different countries. In addition, these studies did not compare treatment lines. In the middle east there were limited studies that addressed the effectiveness of different drugs used to treat RA in Saudi Arabia(5,12-14). These studies were mainly cross sectional in nature or reviews, and it is difficult to draw any conclusions with such study designs. Therefore, this research is to compare the effectiveness of multiple DMARDS medication for the treatment of RA patients in Saudi Arabia. Literature Review Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease that causes irreversible joint deformities which can have debilitating effects on a patient's overall wellbeing. RA has a global prevalence rate of 0.5-1.1% with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population (1). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis. RA is strongly associated with the female gender, with a female to male ratio of 2:1 to 3:1. Smoking habits have also been shown to both increase the risk of acquiring RA and of worsening its prognosis(1,15). Early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state. A study found that only 31% of RA patients visited a rheumatologist within less than 12 weeks of symptom onset, those who did had ameliorated progression rates at 6 years as measured by the Sharp/van der Heijde score (SHS) as well as higher rates of DMARD-free remission than patients who delayed their presentation to more than 12 weeks (16) Even though the importance of optimal treatment has been demonstrated, in Africa and the Middle East diagnoses are often delayed for months or even years after symptom onset(5,12,17,18) Our group conducted a study in Saudi Arabia showed that patients may not receive a diagnosis of RA for up to 30 months after the onset of symptoms (12). Raising public awareness of RA and treatment options is also an important tool for reducing time to diagnosis(17). Public education programs can lead to earlier diagnosis and initiation of therapy, as observed in patients in the United Arab Emirates(19). Increased public awareness may also lead to patients with symptoms of RA visiting rheumatology clinics rather than other specialties, thereby receiving adequate and timely treatment. Delayed diagnoses can be attributed to a variety of reasons. In

NCT ID: NCT06390709 Recruiting - Clinical trials for Rheumatoid Arthritis

PREDICT Therapy Selection for JAK, T-cell, or IL-6 Inhibitor Therapies Using a Molecular Signature Response Classifier (PREDICT)

PREDICT
Start date: April 8, 2024
Phase:
Study type: Observational

Prospective, multi-center-observational study conducted within the US, collecting patient samples for research and development to train, test, and validate precision medicine classifiers. These molecular signature response classifiers (MSRC) aim to predict response status to JAK, T-cell, and IL-6 inhibitor therapies in patients with rheumatoid arthritis (RA).

NCT ID: NCT06384651 Recruiting - Infections Clinical Trials

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

IOTAA
Start date: December 13, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

NCT ID: NCT06383195 Recruiting - Clinical trials for Enthesitis Related Arthritis

The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis

Start date: March 21, 2024
Phase:
Study type: Observational

This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA).

NCT ID: NCT06356350 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Exercise Programs on Gait in Children With Scoliosis Diagnosed JIA

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

Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk (1). These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA (2, 3). All these situations can lead to scoliosis, which we often encounter in children with JIA. Current studies describing various 3-dimension (3D) exercise methods (SEAS, Schroth, Dobomed, BSPTS, Side-shift, Lyon, etc.) effective on scoliosis (4). However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children with scoliosis diagnosed JIA.

NCT ID: NCT06339957 Recruiting - Clinical trials for Rheumatoid Arthritis

Rheumatology Diet Study

Start date: March 1, 2024
Phase:
Study type: Observational

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.

NCT ID: NCT06336252 Recruiting - Heart Failure Clinical Trials

Technology Assisted Nudging to Increase Physical Activity Among Hospitalised Medical Patients

SENS4ME
Start date: April 2024
Phase: N/A
Study type: Interventional

Primary Objective To investigate if patients hospitalised for older adults with a decreased level of physical function, either related to a chronic condition e.g., COPD, Congestive heart failure, renal failure; infections; frailty and tendency of falling; orthopaedic surgery - after hip fracture will increase their time spent out of bed during hospitalisation and 3 months after discharge through visual feedback and motivational intervention about physical activities from a new mobile technology. Hypothesis Patients hospitalised for medical disease will increase their physical activity level during hospitalisation and 3 months after discharge through visual feedback and motivational intervention from a new mobile technology.

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.