Clinical Research Directory

HRV Variation in Rheumatoid Arthritis

The goal of this observational study is to determine the association between continuous Heart Rate Variability (HRV) measured by the Oura ring and Rheumatoid Arthritis (RA) disease activity.

the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis

This multicenter, randomized, double-blind, sham-controlled trial aimed to evaluate the preventive efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) against central-sensitization-related pain in high-risk rheumatoid arthritis (RA) patients. A total of 124 eligible participants were randomized 1:1 to receive 4-week home-based real or sham taVNS. The primary outcome was the change in Central Sensitization Inventory-9 (CSI-9) score from baseline to week 4. Peripheral blood, faecal samples and brain MRI were collected to explore potential brain-gut-microbiome-related mechanisms. Our findings will provide high-quality evidence for this non-pharmacological intervention for RA-related central sensitization pain.

A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.

Pain Neuroscience Education and Vagus Nerve Stimulation on Recovery in Individuals With Rheumatoid Arthritis

In the context of this randomized controlled study, patients who are diagnosed with Rheumatoid arthritis in Cerrahpaşa Faculty of Medicine Hospital, will be taken into a rehabilitation program by a qualified physiotherapist to improve their pain, pain perception, inflammatory markers and quality of life, with one of the pain neuroscience education, vagal nerve stimulation and traditional exercise interventions. The results of each intervention method will be analyzed and compared at the end of the 8 weeks study protocol.

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [Proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \[proposed etanercept biosimilar\] to Enbrel® \[EU-sourced\] in rheumatoid arthritis

the Effect of Ginkgo Biloba on Rheumatoid Arthritis Patients

this study aims to measure The Effect of Gingko Biloba on the Clinical Outcome of Rheumatoid Arthritis Patients ,the outcomes are hsCRp,calprotectin,DAS-28,HAQ-DI

Probiotics in Adults With Rheumatoid Arthritis

The goal of this clinical study is to collect data on the effect of probiotic administration on clinical outcomes in rheumatoid arthritis patients. Participants will: * Have a 6-week daily administration of a probiotic * Collect fecal samples every other day during the first 3 weeks of the study and twice weekly over the last 3 weeks * Visit the clinic at Baseline, Week 3 and Week 6 for checkup and testing

Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \[ulcerative colitis and Crohn's disease\] (IBD) or rheumatoid arthritis (RA). Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control. Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation. Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.

DETECTRA: Remote Monitoring to Detect Rheumatoid Arthritis Flares and Treatment Response

The goal of this clinical trial is to learn if the DETECTRA remote monitoring platform can help clinicians detect rheumatoid arthritis (RA) disease flares earlier and more reliably, as well as identify response and non-response or insufficient response to treatment, compared with standard care. The study will include patients with RA and will follow them for 12 months. The main questions it aims to answer are: In patients with remission or low disease activity (DAS28-CRP ≤ 2.6), does remote monitoring with patient-reported outcomes and self-performed imaging using DETECTRA enable earlier detection of disease flares compared with standard care? In patients with higher disease activity (DAS28-CRP \> 2.6) who have switched medication, does DETECTRA enable earlier and more reliable identification of response and non-response or insufficient response to treatment compared with standard care? Researchers will compare the DETECTRA intervention groups with standard-of-care control groups to see whether remote monitoring enables earlier and more reliable detection of changes in disease activity and treatment response. Participants will: Be assigned to a Low Disease Activity (LDA) or High Disease Activity (HDA) substudy based on their DAS28-CRP score at baseline. Be randomly assigned within their substudy to either the DETECTRA remote monitoring group or the standard-of-care group. In the DETECTRA group, regularly provide patient-reported outcomes and perform self-imaging of their hands remotely using the DETECTRA application. Attend standard clinical assessments and be followed for 12 months.

Rheumatoid Arthritis and Osteosarcopenia: Associated Factors

Our study is a cross-sectional study, and its aim is to compare and analyze the prevalence of sarcopenia and osteoporosis in patients with rheumatoid arthritis (RA) with a control group and to reveal the impact of sarcopenia on osteoporosis, fall risk, and fracture risk. This prospective cross-sectional study will include 100 rheumatoid arthritis patients and 100 healthy controls, matched for age and sex. Patients will be consecutively and meticulously enrolled based on inclusion and exclusion criteria. A detailed medical history and examination will be performed on the patients, and their clinical and sociodemographic characteristics will be recorded. Blood tests for RA (RF, Anti-Cyclic Citrullinated Peptide (anti-CCP), CRP, ESR) and disease activity levels (DAS28) will be recorded. The prevalence of osteosarcopenia will be assessed in both the RA and healthy control groups.These groups will be evaluated using various scales and tests (including power, performance tests) including musculoskeletal ultrasonographic measurements and clinical functional assessment tests. he sarcopenic group will be categorized based on the level of sarcopenia, according to the new ISarcoPRM criteria (non-sarcopenic, dynapenic, sarcopenic, and severe sarcopenic). Osteosarcopenia will be evaluated for both groups, and the collected data will be analyzed with primary and secondary outcomes. The analysis will explore the potential relationships between rheumatoid inflammation, sarcopenia, and osteoporosis.

Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis

The goal of this study is to evaluate the safety, pharmacokinetic (PK) characteristics, and preliminary efficacy of a new oral chemical drug in : adults aged 18-70 years (male or female) with moderate to severe active rheumatoid arthritis (RA), who have had inadequate response to or intolerance of at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) .

National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

PROMESS 1 is a multicenter cohort interventional study aiming at analyzing the factors associated with the risk of developing clinical arthritis among exposures or combinations of exposures in patients at risk of rheumatoid arthritis (RA), as they have high levels of anti-citrullinated peptides autoantibodies (ACPA ≥2 N). The primary endpoint is the occurrence of clinical arthritis confirmed by ultrasound at two years of following for the subject's groups at risk of RA. This may be explained by the following exposures or combinations of exposures: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress. Other factors may also explain the occurrence of clinical arthritis: * Other symptoms * Comorbidities, medical history, drug exposures * Current biology: ACPA levels, rheumatoid factor levels and isotypes, CRP levels at baseline, etc. * Ultrasound and MRI abnormalities.

Improving ILD Screening in Patients With RA and SSc Using EHR-Embedded CDS and PRO Tools

This is a quality improvement initiative that aims to find better ways to identify interstitial lung disease (ILD) early in people with rheumatoid arthritis (RA) or systemic sclerosis (SSc). ILD is a serious lung problem that can develop in these conditions but is often missed. The project will test whether tools built into the electronic health record (EHR), including symptom surveys that patients complete on a tablet and alerts that help doctors decide when lung testing is needed, can increase screening rates. About 16 rheumatology clinics that use the same EHR system will take part. All clinics will eventually use the new tools, but they will start at different times. This allows researchers to compare usual care to the new approach within each clinic. Adults with RA or SSc who have not previously been diagnosed with ILD and who have not had recent lung testing will be included automatically through their routine clinic visits. The study expects to include about 800 patients in total. The main question is whether more eligible patients receive recommended ILD screening, which includes either a pulmonary function test or a high-resolution CT scan, within seven days of their clinic visit. The study will also look at how often lung tests are ordered and completed, how often patients report symptoms such as shortness of breath or cough, and whether the alerts lead to real-time clinical decisions. This project lasts two years and uses information already collected during routine clinical care. No additional procedures or medications are required.

TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs

This is a randomized, double-blind, placebo-controlled parallel-group Phase II study. The study aims to evaluate the efficacy and safety of TLL-018 in adult patients with moderate to severe active rheumatoid arthritis who have inadequate response or intolerance to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Effects of Nonsurgical Periodontal Treatment on GCF Calprotectin and IL-10 in Rheumatoid Arthritis

This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Participants with and without rheumatoid arthritis were classified according to periodontal status as periodontally healthy, gingivitis, or periodontitis. Clinical periodontal measurements and gingival crevicular fluid levels of calprotectin (MRP-8/14) and interleukin-10 (IL-10) were evaluated at baseline, 1 month, and 3 months. Disease Activity Score-28 (DAS28) was also evaluated in participants with rheumatoid arthritis.

A Phase IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis

This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.

Effect of Lavender Aromatherapy Massage on Pain and Wrist Mobility in Rheumatoid Arthritis

This randomized controlled trial aims to evaluate the effect of lavender aromatherapy massage on pain intensity and wrist joint mobility in patients with rheumatoid arthritis. Participants will be randomly assigned to receive lavender aromatherapy massage in addition to standard care or standard care alone. Pain intensity and wrist mobility will be measured before and after the intervention period. The findings of this study may provide evidence regarding the effectiveness of complementary therapies in reducing pain and improving joint function in patients with rheumatoid arthritis.

The Effect of Nicorandil on Rheumatoid Arthritis Patients

The aim of this clinical trial is to determine whether nicorandil works in minimizing disease severity in patients with rheumatoid arthritis. The study will also assess the safety and tolerability of nicorandil. The main questions it aims to answer are: * Could nicorandil improve disease severity and symptoms of rheumatoid arthritis? * Does nicorandil lower the number of times participants need to use pain relieve medications? * Does the nicorandil improve participants functionality and ability to carry out daily activity? * Does nicorandil correct disease-associated damage and inflammation? * What side effects do participants have when taking nicorandil? Researchers will compare nicorandil to a placebo (a look-alike substance that contains no drug) to see if nicorandil works to decrease symptoms and severity of rheumatoid arthritis. Participants will: * Take nicorandil or a placebo two times daily for 3 months * Visit the clinic once every month for checkups * Keep a diary of their symptoms and the number of times they use a pain reliever

At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]

The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.

Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis

This cross-sectional observational study aims to evaluate the validity and reliability of the Four Square Step Test (FSST) in individuals with rheumatoid arthritis. In addition, the study will investigate the associations between FSST performance and clinical parameters including disease activity, quality of life, pain, and muscle strength. All assessments will be conducted according to a pre-defined standardized protocol. The order of measurement tools will be randomized to minimize potential bias, and sufficient rest intervals will be provided between tests to prevent fatigue and performance effects. Participants will include individuals aged 18-65 years with a diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 classification criteria, who have been followed for at least 6 months, have had no major changes in treatment regimen in the last 4 weeks (e.g., initiation or change of DMARDs/biologics, high-dose steroid increase), can walk at least 10 meters independently, have a Mini-Mental State Examination score of 24 or higher, and are able to follow verbal instructions in Turkish to comply with study procedures. Appropriate statistical methods will be applied to assess validity, reliability, and associations between FSST and clinical parameters.

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.

Discontinuation of Disease-modifying Anti-rheumatic Drugs (DMARDs) in Rheumatoid Arthritis Patients Also Using TNF Inhibitors

The goal is to investigate whether a strategy of attempting to discontinue of MTX or LEF (and restart when necessary) in RA patients treated with an optimal dose (allowed dose or lower, tapered to the maximum, or according to patient preference) TNFi is not worser to a continuation of combination therapy. The study will also examine the disease-related effects of treatment that attempts to discontinue MTX or LEF, how patients experience it, its safety, and its impact on medication usage and healthcare costs. The main outcome is the difference between treatments in average disease activity over 24 months. The study will compare whether disease activity remains similar between patients who attempt to discontinue MTX or LEF and those who continue combination therapy. Patients will be followed for 24 months with scheduled hospital visits at baseline, after 3, 6, 12, 18, and 24 months, remote visits, and additional visits for disease flares. X-rays of the hands and feet will be taken at baseline and after 24 months. During some visits, additional blood samples will be taken to measure inflammation markers and medication levels.

Evaluation of Functional Disability in Rheumatoid Arthritis Patients

Rheumatoid arthritis (RA) is a chronic, systemic, autoimmune inflammatory disease that mainly affects the joints and periarticular soft tissues. Accurate monitoring of disease activity is a cornerstone of the treat-to-target approach in Rheumatoid arthritis.

FT839 in Autoimmune Diseases

The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or conditioning therapy.