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Arthritis clinical trials at University of California Health

30 in progress, 16 open to eligible people

Showing trials for
  • Adalimumab in JIA-associated Uveitis Stopping Trial

    open to eligible people ages 2 years and up

    The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).

    at UC Davis UCSF

  • Biofeedback Retention in Individuals With AKA

    open to eligible people ages 18-70

    More than two million Americans are currently living with a full or partial limb loss, and an additional 185,000 amputations occur each year. The majority of amputations occur in the lower limbs. There are many potential causes for amputation, but the majority can be attributed to vascular diseases, such as diabetes, traumatic injury, and cancer. For these individuals, prosthetic devices play an important role in restoring mobility and enabling them to participate in everyday activities. However, when learning to use these devices, patients often alter their movement patterns to compensate for pain or discomfort, a decreased ability to feel what their prosthetic limb is doing, and/or a fear of falling. By changing their movement patterns, patients will tend to am their intact leg, which has been shown to lead to long-term joint damage and chronic injury. For perspective, 75% of United States veterans living with amputation are diagnosed with a subsequent disease affecting their muscle, bone, and/or joint health. Therefore, therapy sessions, known as gait retraining, are an integral part of teaching prosthesis users to walk in a safe and efficient manner. With recent advances in wearable technology, researchers and therapists have begun exploring the use of biofeedback systems to assist with this retraining. In these systems, wearable sensors are used to measure how the patient is moving in real-time, and can provide information on how much time they spend on each leg and how much each joint moves during walking. Biofeedback refers to the process of communicating the information from these sensors back to the patients instruct them whether they need to change their movements. Previous research has shown that these systems have excellent potential for helping patients with physical disabilities improve their quality of motion. However, relatively little research has explored how well individuals with above-knee leg amputations respond to biofeedback during gait retraining. Importantly, the question of whether the new movement patterns taught using biofeedback will persist after training has finished remains unanswered. Therefore, the primary objective of this research is to determine whether biofeedback is a feasible tool for gait retraining with above-knee prosthesis (including a prosthetic knee, ankle, and foot) users. To answer these questions, forty individuals currently using above-knee prosthetic systems will undergo a single session of biofeedback training. Half of these populations will be from the civilian population, and half will be military veterans. During this training, the biofeedback system will apply short vibrations - similar to those generated by cellphones - to their skin every time that the patient reaches the desired degree of hip rotation during walking. Participants will be instructed to keep increasing their hip motion until they feel a vibration on every step. Before training, they will be instrumented with a wearable motion captures system, pressure sensors embedded in their shoes, and a wearable heart rate monitor. Using these devices, researchers will measure the participants' walking patterns without biofeedback determine their current ability. Once training is complete, their walking patterns will be measured again, first while using the biofeedback system, and then again fifteen minutes and thirty minutes after the biofeedback system has been removed. The data measured during these tests will enable researchers to calculate functional mobility scores that are used to evaluate the quality of a patient's walking, and then compare how these scores change before, during, and after biofeedback training. The knowledge gained through this research constitutes a critical step towards identifying optimal biofeedback strategies for maximizing patient mobility outcomes. The findings will be essential for the development of gait retraining protocols designed to reduce the incidence of chronic injury, and enable patients to achieve their full mobility potential. Building on these results, the next research phase will be to incorporate biofeedback training into a standard six-week gait retraining protocol to evaluate its long-term effectiveness as a rehabilitation tool. Unlike traditional gait retraining, which requires patients to visit clinics in-person for all sessions, the wearable, automated nature of biofeedback training will allow patients to continue gait training from home. This ability will enable patients to continue training activities between sessions, and ultimately may be able to substitute for some in-person visits. This potential for remote therapy has exciting implications for improved access to care for individuals living long distances from their rehabilitation providers, or those suffering from social anxiety, as well as during global health pandemics where in-person visits are difficult.

    at UCSF

  • Omadacycline Randomized Treatment Given for Bone and Joint Infection

    open to eligible people ages 18-85

    The study design is a randomized, open-label, clinical trial of omadacycline vs Standard of Care (SOC) antibiotics for bone and join infection (BJI) treatment. Study participants will have their BJI regimen chosen by their treating physicians, (typically Infectious Diseases for hardware and prosthetic joint infections, or multidisciplinary Limb Salvage team for diabetic foot infections) prior to enrollment. Then participants will be randomized to an omadacycline-containing regimen versus the a priori chosen SOC regimen. Participants must require between 4 and 12 weeks of therapy for their BJI. The exact duration of therapy will be decided by the participants' treating physician. At 12 weeks, if the treating physician wishes to extend therapy, participants receiving omadacycline will be transitioned to other SOC antibiotics. Once enrolled, participants will be followed via in-person clinic visits at the following intervals: weeks 0, 2, 4, 8, and 12. A final in-person visit will occur 2 weeks post-treatment completion. A phone survey will occur 3 months post-treatment completion. Participants in the SOC group will follow the same schedule. Oral once-daily dosing options for S. aureus and Coagulase negative Staphylococcus are essentially non-existent. Thus, omadacycline possesses a novel and advantageous option for BJI treatment. Its convenient dosing regimen will almost certainly be associated with improved adherence, and higher adherence may, in turn, improve clinical outcome. Investigators hypothesize that omadacycline will be a well-tolerated and efficacious oral antibiotic for BJIs and will be associated with improved adherence compared with standard of care oral antibiotics. Investigators believe omadacycline addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for BJIs. To this aim, investigators will perform a randomized, open-label clinical trial of omadacycline to SOC antibiotics for BJIs.

    at UCLA

  • Anti-inflammatory Diet in Rheumatoid Arthritis

    open to eligible people ages 18 years and up

    In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.

    at UCSD

  • Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

    open to eligible people ages 18 years and up

    This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

    at UC Davis

  • RA-PRO PRAGMATIC TRIAL

    open to eligible people ages 18 years and up

    The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.

    at UCLA

  • Rheumatoid Arthritis Shared Decision Making

    open to eligible people ages 18 years and up

    Shared decision making is the first overarching principle for the treat to target guidelines for rheumatoid arthritis (RA) and has been proposed as a potential mechanism to reduce health disparities, however there is little evidence to inform effective ways to implement this practice in the care of Veterans with RA. The purpose of this project is to evaluate the effectiveness of a multi-component shared decision making intervention on RA disease activity, adherence to RA medications and patient knowledge of RA. The proposed research will contribute to fundamental knowledge about how to effectively foster shared decision making across varied VA rheumatology clinical settings to improve patient disease outcomes and experience; and support clinicians to engage patients in meaningful ways with the ultimate goal to improve health, reduce disability, and eliminate disparities.

    at UCSF

  • Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

    open to eligible people ages 40-75

    The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.

    at UCSD

  • Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

    open to eligible people ages 18 years and up

    Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

    at UCLA

  • Tc 99m Tilmanocept Imaging for Early Prediction of Anti-TNFα Therapy Response in Moderate to Severe Active RA

    open to eligible people ages 18 years and up

    This study will confirm the ability of Tc 99m tilmanocept imaging to predict clinical response in individuals with RA who are beginning anti-TNFα therapy.

    at UCSF

  • Transcutaneous Vagus Nerve Stimulation (tcVNS) in JIA

    open to eligible people ages 5-18

    The study is a multicenter, double-blind, sham-controlled trial to evaluate the safety and effectiveness of tcVNS on pain and inflammation associated with JIA. tcVNS is administered with a device that gives off mild electrical impulses through the skin to stimulate the vagus nerve. Part of the vagus nerve and its branches are located in the head and neck. For this study, the impulses will be administered in areas overlying the vagus nerve using a small electrode. The electrode helps to conduct the stimulation through the skin. This stimulation triggers a chemical response through the nerves and has been found to be effective in reducing pain and inflammation in several diseases. The primary objective of this study is to determine the effect of tcVNS on JIA ACR 50 in participants with active JIA. The components of the active and sham tcVNS devices, utilizing the Roscoe Medical TENS 7000, have been FDA 510(k)-cleared and have been determined by the IRB to be a nonsignificant risk device.

    at UCSF

  • Acthar in Rheumatoid Arthritis (RA) Related Flares

    open to eligible people ages 18 years and up

    This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

    at UCLA

  • Sustained Dynamic Compression Intramedullary Nail for Subtalar Arthrodesis

    open to eligible people ages 18 years and up

    The purpose of this study is to determine the clinical efficacy of a novel dynamic sustained compression intramedullary nail for subtalar (talocalcaneal) arthrodesis.

    at UC Davis

  • OTIS Autoimmune Diseases in Pregnancy Project

    open to eligible females

    The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

    at UCSD

  • Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

    open to eligible people ages 18 years and up

    This is a prospective, observational study of patients presenting to the emergency departments at 9 EMERGEncy ID NET sites. The objectives of the proposed study are to: 1. Describe the range and proportion of infectious agents in synovial fluid as detected by standard C&S and investigational PCR testing, i.e., Biofire® Film Array® Bone and Joint Infection (BJI) Panel, 2. Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED), 3. Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and 4. Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis. Study coordinators screen the ED log for adult patients presenting with joint pain and whose treating physician ordered an arthrocentesis. After confirming eligibility, study coordinators approach the patient to explain the study, and present the written consent form. If the patient agrees to participate and consent, the study coordinator completes an enrollment data collection using patient and treating physician interview to gather responses. After enrollment, the study coordinator will ensure that approximately 0.3-1.0 mL of leftover synovial fluid is saved and stored in a freezer for shipment to a central laboratory (Truman Medical Center hospital laboratory, Kansas City, MO) for testing. Approximately 30 days after enrollment, study coordinators complete an electronic medical record (EMR) review.

    at UCLA

  • Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

    open to eligible females

    The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

    at UCSD

  • Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

    Sorry, in progress, not accepting new patients

    This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

    at UCLA

  • Advancing Understanding of Transportation Options

    Sorry, in progress, not accepting new patients

    This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

    at UCSD

  • CD40L Antagonism in Rheumatoid Arthritis (RA)

    Sorry, in progress, not accepting new patients

    The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi.

    at UCSF

  • COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

    Sorry, in progress, not accepting new patients

    This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: - Systemic Lupus Erythematosus (SLE) - Rheumatoid Arthritis (RA) - Multiple Sclerosis (MS) - Systemic Sclerosis (SSc), and - Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: - Systemic Lupus Erythematosus (SLE) - Juvenile Idiopathic Arthritis (JIA) - Pediatric-Onset Multiple Sclerosis (POMS) - Juvenile Dermatomyositis (JDM)

    at UCLA

  • Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

    at UCSD

  • Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis

    Sorry, not yet accepting patients

    This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.

    at UCLA

  • Pediatric Arthritis Study of Certolizumab Pegol

    Sorry, in progress, not accepting new patients

    A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).

    at UCSF

  • Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

    Sorry, in progress, not accepting new patients

    This is a research study to test whether a once-weekly injection of abatacept will prevent the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication within 18 months of randomization in children with recent-onset limited JIA.

    at UCSF

  • Activity of TRL1068 in Prosthetic Joint Infections

    Sorry, in progress, not accepting new patients

    TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.

    at UCLA

  • Zimmer Trabecular Metal Total Ankle PMCF

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle implants used in primary or revision total ankle arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

    at UC Davis

  • Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

    Sorry, currently not accepting new patients, but might later

    This is a single center exploratory imaging study investigating the initial application of zirconium-89 Deferoxamine B Certolizumab pegol (89Zr-DFO-CZP) PET in patients with rheumatoid arthritis. Patients with active symptoms of RA or signs on physical exam will be invited to participate for PET imaging.

    at UCSF

  • Apremilast Pregnancy Exposure Registry

    Sorry, in progress, not accepting new patients

    The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.

    at UCSD

  • Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

    Sorry, accepting new patients by invitation only

    Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement

    at UCSD

  • Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

    Sorry, in progress, not accepting new patients

    The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

    at UCSF

Our lead scientists for Arthritis research studies include .

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