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Rheumatoid Arthritis clinical trials

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NCT ID: NCT05913817 Recruiting - Clinical trials for Rheumatoid Arthritis

The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.

EASE PAIN
Start date: January 9, 2023
Phase:
Study type: Observational

The purpose of the Phase IV study is to investigate the effects of both Volume and Citrate on Injection Site Pain (ISP), adherence, patient satisfaction, Quality of Life, and Disease Assessment in the Canadian Adalimumab Market. The phase IV study is an observational, pan-Canadian, multidisciplinary study aiming to enroll 600 patients across 50-70 sites across 3 different Therapeutic Areas (GI, Rheum, Derm).

NCT ID: NCT05911880 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of a Plant-based Diet on the Active Rheumatoid Arthritis Activity.

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

The increase in autoimmune diseases in Western countries has been linked to environmental factors, and diet is considered a modifier of rheumatoid arthritis (RA). A high-fat diet promotes systemic inflammation and alters the microbiome. Certain bacteria in the intestinal microbiota generate proinflammatory metabolites from components of red meat, eggs, and dairy products. However, fruits and vegetables can modulate the gut microbiota and have been associated with reduced inflammation in RA patients. The aim of this study is to determine the changes in RA activity associated with plant-based dietary modifications. The study will evaluate men and women aged 18 years and older with low, moderate, or severe RA activity, and the intervention will involve an individualized, isocaloric plant-based diet for 14 days. The 28-joint disease activity score index and c-reactive protein (DAS 28-PCR) will be used to determine disease severity, in addition to analyzing the expression of inflammatory cytokines and microRNAs associated with RA.

NCT ID: NCT05904301 Recruiting - Clinical trials for Rheumatoid Arthritis

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

NAREG
Start date: June 21, 2023
Phase:
Study type: Observational

Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.

NCT ID: NCT05892562 Recruiting - Depression Clinical Trials

A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis

Start date: December 15, 2022
Phase:
Study type: Observational

Rheumatoid arthritis (RA) is a systemic chronic inflammatory disease, and depression and anxiety are among the most common comorbidities in RA patients, with a high prevalence rate. Epidemiological studies have found that joint deformities, severe pain, positive serum RF titers, as well as comorbidities such as hypertension, insomnia, pain, and fatigue are significantly associated with depression and anxiety in RA patients. Currently, clinical studies have found that the relief of depression or anxiety is one of the expected treatment goals for RA patients. Due to the unclear pathogenic factors of depression or anxiety in RA patients, there is a lack of effective clinical treatment options. Therefore, this study will use a "causal inference model" to identify possible "mediating variables" that may lead to the comorbidity of RA and emotional disorders through clinical investigation, aiming to improve the precision of treatment for physicians.

NCT ID: NCT05888181 Recruiting - Clinical trials for Rheumatoid Arthritis

App-based Education and GOal-setting in Rheumatoid Arthritis

AEGORA
Start date: March 3, 2023
Phase: N/A
Study type: Interventional

The purpose of this pragmatic, investigator-initiated, multicentre randomised controlled trial is to study the effectiveness and feasibility of a mobile app-based self-management intervention for patients with rheumatoid arthritis (RA), aiming to improve self-efficacy for the management of RA-related symptoms. The intervention consists of education, lifestyle advice and remote monitoring elements and is based on principles of goal setting, self-efficacy theory and behavioural economics, embedded within a platform supported by motivational features and gamification. The primary endpoint is defined as achieving at least a minimal clinically important difference in arthritis-related self-efficacy (the ASES-score) at the follow-up visit in favour of the intervention group when compared to the control group. Moreover, although qualitative studies have highlighted concerns among both patients and healthcare professionals that mobile apps might induce illness behaviour by increasing patients' awareness of their symptoms, this has rarely been studied in detail. Consequently, data regarding the effects of remote monitoring on symptom hypervigilance remain limited and conflicting. Therefore, this trial additionally aims to assess (as a key secondary objective) if a mobile app-based intervention is associated with changes in pain catastrophising, as a conceptualisation of hypervigilance to symptoms.

NCT ID: NCT05880303 Recruiting - Clinical trials for Rheumatoid Arthritis

Effect of Nonsurgical Periodontal Therapy (NSPT) on Rheumatoid Arthritis Subjects With Periodontitis

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

Periodontitis (PD), a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and, if left untreated, tooth loss. Rheumatoid arthritis (RA), is an autoimmune disease characterized as a chronic inflammatory disorder leading to synovial inflammation and destruction of cartilage and bone. RA and PD which are commonly seen in elderly have many similarities in terms of pathophysiology and clinical progression. Previous findings from the investigators reported that inflamed periodontal tissues of RA subjects with PD are a potential site for post translational modification of proteins as there was increase in presence of citrullinated and carbamylated proteins in gingival tissues. Autoantibodies to these proteins have been reported to be involved in loss of immune tolerance which leads to RA and its progression. Currently there are gaps in our knowledge concerning the effect of nonsurgical periodontal therapy (NSTP), comprising oral hygiene instructions, scaling and root surface debridement on presence of these autoantibodies and inflammatory outcomes of RA. It is hypothesized that reduction in periodontal inflammation may concurrently reduce the systemic inflammatory load which is responsible in perpetuating RA joint inflammation. Here, the investigators propose to perform a randomized, controlled, single-blinded study on RA subjects with stage 2 or 3 periodontitis to assess the effect of NSTP on the reduction of these autoantibodies and inflammatory mediators as well as RA related disease activity measures such as ESR, CRP and Disease Activity Score 28-joint count (DAS28). The investigators will also assess changes in subgingival microbiota associated with RA-PD in response to NSTP using next generation sequencing. This study will help determine if RA individuals could benefit from early and appropriate NSPT, thus reducing periodontal inflammation and a similar impact on RA disease could be expected. This will ultimately improve patients' quality of life and reduce societal burden related to increased patient discomfort and treatment costs.

NCT ID: NCT05879419 Recruiting - Clinical trials for Rheumatoid Arthritis

Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

RZVRheum
Start date: May 23, 2023
Phase: Phase 4
Study type: Interventional

Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ. Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ. Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.

NCT ID: NCT05869370 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effects Of Low Intensity Training With Blood Flow Restriction In Rheumatoid Arthritis Patients

TBFR
Start date: May 20, 2018
Phase: N/A
Study type: Interventional

Rheumatoid arthritis (RA) patients showed systemic manifestations that may lead to a reduction in muscle strength, muscle mass and, consequently, to a reduction in physical function. On the other hand, high intensity resistance training (HIRT) are able to improve muscle strength and muscle mass in RA without affecting the disease course. However, due to the articular manifestations caused by this disease, these patients may present intolerance to HIRT. Thus, the low intensity resistance training with blood flow restriction (TBFR) may be a new training strategy for these populations. In this sense, the investigators speculate that TBFR could be beneficial in RA patients, as well as, HIRT.

NCT ID: NCT05866614 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps

Start date: January 13, 2023
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

NCT ID: NCT05861934 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality

Start date: November 20, 2022
Phase: N/A
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic, multisystemic, progressive autoimmune disease characterized by joint destruction in synovial tissue, causing joint swelling, pain and morning stiffness. It is estimated to affect 0.1%-2% of the world's adult population and more women than men. RA limits individuals' work, social, and home lives and functional capacities. Patients commonly experience pain and accompanying sleep problems. Interventions for these problems and symptom management are important. In this regard, this study was planned to examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.