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Arthritis, Rheumatoid clinical trials

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NCT ID: NCT06293365 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

NCT ID: NCT06273306 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

IMIDOC
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.

NCT ID: NCT06245265 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of Non-Surgical Periodontal Therapy on Rheumatoid Arthritis

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

Periodontitis is a common chronic inflammatory disease characterised by the destruction of the soft and hard tissues supporting the tooth, including alveolar bone, periodontal ligament and cementum. Periodontitis has been associated with different host characteristics such as diabetes or neutrophil disorders and environmental factors such as smoking, alcohol consumption and stress. On the other hand, periodontal bacterial infection triggers a systemic immune response that is associated with an increased risk of different disorders such as bacterial pneumonia, cardiovascular disease and autoimmune diseases. Rheumatoid arthritis (RA) is a severe chronic autoimmune disease of unknown etiology, characterised by symmetrical, erosive synovitis of the joints, sometimes with multisystem organ involvement, joint destruction and excessive bone loss. Although the etiology of RA is unknown, it is thought to occur in individuals with genetic predisposition as a result of exposure to various environmental factors. RA and periodontitis are chronic destructive inflammatory diseases with common genetic and environmental risk factors, pathogenesis mechanisms and complex multifactorial pathological processes. Several studies suggest that periodontitis, a common inflammatory disease of the periodontium surrounding the teeth and triggered by bacteria in the mouth, is associated with RA and may initiate and worsen inflammation in RA. Non-surgical periodontal treatment (COPT), which is considered the gold standard in the treatment of periodontitis with hand instruments and ultrasonic instruments, has been shown to provide significant improvements in the clinical outcomes of periodontitis patients with RA. COPT is performed to stop the progression of periodontal diseases. Considering the studies supporting the bidirectional relationship between periodontitis and RA, it is thought that COPT may affect the clinical and biochemical values of RA. Based on these points, the aim of our study was to investigate the relationship between serum and salivary ANGPTL-4, MMP-13, TNF-α and IL-6 levels and periodontal disease in individuals with RA and to evaluate the effects of COPT on RA disease severity in vivo.

NCT ID: NCT06240299 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Neurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR)

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

Rheumatoid arthritis is an autoimmune condition, causing inflammation and pain. Yet pain may persist even when inflammation has been treated. This residual pain, called nociplastic pain, has symptoms of a chronic pain condition called fibromyalgia. There are few effective therapies to address this residual pain. Published literature shows that fibromyalgia can be treated by neurofeedback, a noninvasive method that is based on the voluntary modulation of cortical activity. In this pilot study, the investigators want to test the effect of neurofeedback on the fibromyalgia component of pain in rheumatoid arthritis, and also to investigate its effects on related symptoms such as fatigue and sleep disturbance.

NCT ID: NCT06235645 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

EARLIER
Start date: March 2024
Phase:
Study type: Observational

Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD). RA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients. The prevalence of RA-ILD varies according to the screening tool used. The current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established. Lung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF). LUS is a non-irradiating, non-expensive examination that can be performed rapidly. The aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.

NCT ID: NCT06233929 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)

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

An ongoing long-term cohort study is conducted in the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, that is dedicated to recruiting RA patients, to identify the development of clinical, neuroimaging, and biochemical biomarkers for the diagnosis and prognosis of RA, especially for those with sarcopenia/myopenia To improve the prognosis of RA, this study includes the following objectives: 1. Construct a useful database to explore the secular dynamic progress of RA, especially the difference between early and lately RA, as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities. 2. Identify the potential markers (clinical, biomedical and imaging) affecting/predicting the development process of sarcopenia/myopenia or other prognosis in RA patients. 3. Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.

NCT ID: NCT06227442 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Renal Resistive Index as a Predictor of Renal Involvement in Rheumatoid Arthritis

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

Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.

NCT ID: NCT06217172 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

RHEUPP - A Rheumatological Follow-up Management App

RHEUPP
Start date: January 2024
Phase: N/A
Study type: Interventional

The purpose of this Non-inferiority Randomized Clinical Trial is to evaluate the effectiveness of RHEUPP App during telehealth follow-up in a population of Rheumatoid Arthritis patients from a Tertiary Rheumatology Service in South Brazil. The main question[s] it aims to answer are: • Using RHEUPP App in telemedicine is not inferior to usual care in terms of means obtained by CDAI. Participants will be stratified by CDAI and then randomized 1:1 for intervention or control group. They will be evaluated at study starting, in 3 and 6 months, an extended evaluation after 12 months of recruitment is predicted. Researchers will compare intervention and control group to detect differences between usual care and Telehealth follow-up and determine if the last is not less effective in our study population of rheumatic patients.

NCT ID: NCT06189495 Not yet recruiting - Clinical trials for Systemic Sclerosis Associated Interstitial Lung Disease

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease

Start date: December 30, 2023
Phase: Phase 2
Study type: Interventional

This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)

NCT ID: NCT06181786 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

A Study of IMB-101 in Healthy Volunteers and Participants With Rheumatoid Arthritis

Start date: December 13, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of IMB-101 in healthy volunteers and participants with active RA on a stable regimen of methotrexate.