Clinical Research Directory

Studies of the Natural History of Rheumatic Diseases

This study will explore the causes of rheumatic diseases and why many of them affect certain minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body s defense against disease. Some rheumatic diseases are painful or deforming and some can be life threatening. Information obtained from this study will be used to learn about the disparities in rheumatic disease in the minority community and to design further, more targeted, research studies to address this issue. Patients with known or suspected rheumatic disease 18 years of age or older may be eligible for this study. Candidates will undergo a medical history and physical examination to confirm the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment. Participants will receive standard medical care for rheumatic disease and arthritis. No experimental treatments, medications or procedures will be included in this study. Procedures may include routine blood tests for blood chemistries, cell counts, and antibodies commonly found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and other imaging tests to check for abnormalities in the lungs or other organs. All medical information will be kept confidential. Patients who are found to be eligible for other current NIH research studies will be offered an opportunity to participate in these studies....

Effects of Aerobic Exercise in Rheumatoid Arthritis

This study aims to evaluate the effects of aerobic exercise therapy on quality of life, functional capacity, mood, and fatigue in patients with rheumatoid arthritis. Additionally, the study investigates the impact of aerobic exercise on inflammatory markers, pain, and disease activity.

Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.

SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Rheumatology Patient Registry and Biorepository

To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

A Study of SPY072 in Rheumatic Disease

This is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and safety of SPY072 compared to placebo in adults (aged ≥18 years) with rheumatic disease (RD).

Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes

Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.

Exploring and Measuring the Impact of Steroids in Children and Young People

Assessing the impact of glucocorticoids in children and young people with rheumatic conditions, to develop a patient reported outcome measure (PROM). Glucocorticoids, also known as steroids, are a very effective medication for the treatment of rheumatological conditions. They are used to reduce inflammation, pain and damage to organs. However, steroids can have some unwanted side effects, such as, increased weight, skin changes, feeling anxious, delayed puberty, diabetes and loss of bone mass. These side effects can therefore impact children and young people's health related quality of life (HRQoL). The investigators would like to create a new questionnaire for children and young people (CYP) who take steroids due to their rheumatological condition. The questionnaire, called a Patient Reported Outcome Measure, (PROM), will measure how steroids are affecting CYP. The first step in creating the questionnaire is to talk to children, young people and their parents/guardians about their experiences of taking steroids. The investigators plan to do this in focus groups, with people around the same age. The second step will then be to take everything people said in the focus group to create the questions in the questionnaire. Cognitive interviewing will then be used in a structured one on one interview to test for relevance, clarity and understanding of the questions. Children, young people and their parents/guardians will be involved throughout the research. Children and young people will give their thoughts and feedback on resources created for participants (consent forms/assent forms/participation information sheet/interview schedule), as well as how the focus groups and cognitive interviews should be structured. With consent, participants will be provided with a lay summary of the results. Results will also be published within peer-reviewed journals, special interest groups, trial meetings, patient charity meetings and presented at conferences.

The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions

People with rheumatic conditions often take many medications, but more pills can increase the risk of side effects, especially in older adults. Some drugs (such as those intended to help pain or sleep) may cause more harm than good in the long term, and others may simply be no longer needed. These are known as 'potentially inappropriate medications' (PIMs). This quality improvement study focuses on people with rheumatic conditions aged 60 and over who take 5 or more daily medications. The goal of the study is to learn if a publicly available physician tool, MedSafer, combined with educational brochures (for patients), can help to reduce PIMs in this group. Researchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following 'bundle': * MedSafer reports provided to treating physicians * EMPOWER consumer brochures provided to patients Participants will be followed over 4 study visits (for 14-18 months) during which researchers will collect information on medication changes and serious adverse events (emergency visits or hospitalizations) and will complete questionnaires measuring quality of life.

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.

The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.

Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy

The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs. Despite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation. The assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy. Through this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.

Accuracy of CBC Derived Markers Against CRP and ESR in Detecting Active Rheumatoid Arthritis in Upper Egypt

Rheumatoid arthritis (RA) is a chronic autoimmune disease that leads to persistent synovial inflammation, joint destruction, and disability, often with extra-articular manifestations like interstitial pneumonia. It predominantly affects middle-aged individuals, especially women. Early diagnosis and accurate disease activity assessment are crucial to prevent irreversible joint damage and systemic complications (4). Clinical tools like the Disease Activity Score in 28 joints (DAS28) are commonly used to monitor RA, relying on inflammatory markers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). However, CRP and ESR can be influenced by factors unrelated to RA, such as infections or anemia, and may not always be available or cost-effective in resource-limited settings (1). In recent years, complete blood count (CBC)-derived markers have emerged as affordable and accessible alternatives for assessing systemic inflammation. These include the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and red cell distribution width (RDW). These indices have shown strong correlations with RA disease activity in various studies, particularly NLR and RDW, which have high sensitivity and specificity for detecting active disease (2-3). Studies in Egypt have explored the diagnostic accuracy of CBC-derived markers and composite indices like the CRP-to-albumin ratio (CAR) and albumin-to-fibrinogen ratio (AFR). These markers correlate significantly with DAS28 scores, suggesting they may be reliable indicators of RA disease activity in Egyptian patients (1-3).

Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain

This study, in a quasi-experimental pre-post design, investigates the effect of serial water-filtered whole-body hyperthermia on circadian core body temperature, the somatosensory system (nociception) and pain perception in healthy and patients with chronic primary pain (e.g., fibromyalgia). The intervention lasts 3 weeks with two treatment sessions per week.

Clinical Trial Phase I/IIa to Evaluate the Safety and Immunogenicity of StreptInCor

This is a Phase I/IIa, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to test the candidate vaccine StreptInCor. The study will include four different doses (25 µg, 50 µg, 100 µg, and 200 µg) of StreptInCor produced under Good Manufacturing Practices (GMP) and formulated with aluminum hydroxide as the vaccine adjuvant. The adjuvant alone will be used as a placebo in this trial. Five groups, each consisting of twelve healthy adult volunteers, will randomly receive two doses of the vaccine or placebo with a 28-day interval, along with a booster dose six months after the initial vaccination

Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease

Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.

Personalized Outreach for Equitable Treatment in Rheumatology

The primary goal of this study is to determine whether providing patient honoraria and/or outreach services can improve the attendance rate of appointments at an inner city rheumatology clinic in Vancouver, British Columbia. The main question it aims to answer are: * Does providing a financial honorarium ($20 for each follow-up appointment with completed bloodwork) improve attendance rate at an inner city rheumatology clinic? * Does providing a personalized outreach service for rheumatic diseases improve attendance rate at an inner city rheumatology clinic? The researchers will compare providing patient honoraria to providing both honoraria and outreach services, and compare each of these to the regular appointment schedule without honoraria or outreach. Participants will: * Undergo randomization to receive honoraria or honoraria and outreach services together * Complete surveys about their health and understanding of their rheumatic disease at baseline, 3-month, and 6-month intervals * Visit the clinic every month for check-ups and monitoring bloodwork if they are started on immunosuppressants for their condition

Impact of Different Exercise Programs on Knee OA

This study will examine and compare the changes in serum biomarkers, joint kinematics, and thigh muscle strength based on three different 8-week exercise protocols in individuals with knee pathology: Lower-body positive-pressure (LBPP) supported low-load treadmill walking and Aquatic exercise program and standard of care treadmill or community walking. Investigators hypothesize that both the 8-week exercise programs which aim to partially off-load the knee joint will be associated with a significant reduction in serum biological markers of joint disease (tissue turnover, cartilage degradation and inflammation) in response to the exercise. The serum biological markers will be directly correlated to participant reported knee pain. Both the LBPP-supported low-load and the aquatic exercise regimens will result in significant increases in thigh muscle strength about the degenerative knee which in-turn will result in diminished knee pain and enhanced joint function. Investigators aim to compare these two exercise programs to understand if benefits of one far exceeds the other as compared to standard of care treadmill or community walking.

Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting

The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.

Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

Systemic rheumatological diseases often occur in young women of childbearing age and can therefore impact fertility. There are diseases, such as arthritis, which present no contraindication to assisted reproductive techniques (ARTs), because there is no influence on the disease itself if the disease activity at conception is stable. On the other hand, patients suffering from connective tissue diseases, primarily Systemic Lupus Erythematosus (SLE) and patients suffering from primary or SLE-related Anti-Phospholipid Antibody Syndrome (APS), deserve more targeted therapies both in the context of ARTs and in the ensuing pregnancy. To evaluate the response to ARTs in patients with systemic rheumatological diseases, both in terms of reactivation of the underlying pathology and in terms of ARTs outcome.

Calcium Pyrophosphate Deposition (CPPD) Disease

The goal of this clinical trial is to describe the transcriptomic and metabolomic profile of patients with chronic Calcium Pyrophosphate Deposition (CPPD) compared to those with acute CPPD. The hypotheses are as follows : * It is hypothesised that there is a transcriptomic and metabolomic signature of CPPD which explains why therapeutic responses to different anti-inflammatory treatments differ from one phenotype to another one * It is hypothesised that the acute and chronic clinical phenotypes of CPPD have different clinical, biological and imaging characteristics, as well as a differing predisposition toward crystalline deposition and inflammatory pathway activation. The management of participants with chronic forms of the disease included in this research was modelled on the usual recommended management, including a biological workup, joint puncture, ultrasound and radiographic workup. Double-energy CT scans and transcriptomic and metabolomic analyses on plasma are not routine tests.

Network to Understand Reproductive Rheumatology Registry

The purpose of the NURTURE Registry is to enroll those who are pregnant and/or potentially capable of pregnancy. Participants will complete patient-reported surveys at enrollment and periodically prior to conception, during pregnancy, and following the completion of the study pregnancy. The study rheumatologist will provide the patient's diagnosis and record rheumatic disease activity at each clinic visit. Medication use, vital signs, and routine laboratory assessments will be collected throughout this period. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys. This Registry will provide a rich data repository for research to improve pregnancy and birth outcomes for women with rheumatic diseases and will be used in on-going and future research to better understand the risk factors that are associated with poor pregnancy outcomes, including preterm birth, intrauterine growth restriction, and preeclampsia, as well as the effects of medication on disease management in pregnancy. Infant outcomes, medications, provider care, pregnancy planning, and social determinants of health on pregnancy and pregnancy outcomes will also be collected. The majority of the information collected in NURTURE, such as labs, disease activity, and medications, PRO's will originate from the EHR. Upon consent, participants will complete an enrollment survey that will include relevant patient reported measures. No study visits outside of routine care will occur. Participants may also complete a yearly survey about their reproductive health journey. The registry will be ongoing and will include periodic analysis of clinical data within this protocol. Additional analysis will be covered under seperate IRB approved protocols. Enrollment in the registry does not significantly increase the risk for a patient.

Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

To establish the efficacy of a community-based POL (Popular Opinion Leader) intervention with two different trainings designed to increase COVID-19 vaccine and booster uptake and reduce hesitancy among social networks of Black individuals with rheumatic conditions. The investigators will also determine the structure and composition of the personal and outreach social networks of POLs.