Clinical Research Directory

A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases

The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases. An autoimmune disease is a condition that makes a person's immune system attack its healthy cells by mistake. This study is particularly looking at autoimmune diseases called as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc). This study is divided into 3 parts: Part 1a, Part 1b and Part 2. Parts 1a and 1b are seeking participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis and Part 2 with also Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc). Participants can take part only in one part of the study. All participants in this study will receive PF-08154225 at the study clinic. In Part 1a participants will receive single administration of PF-08154225 after which they will be observed at the study clinic during regular visits through week 16 or longer. In Part 1b the participants will receive multiple administration of PF-08154225 after which they will be monitored in similar a manner as in Part 1a through week 24 or longer. In Part 2 participants will receive multiple administrations of PF-08154225. After the last injection they will be monitored for safety through week 52 or longer.

Study of Families With Twins or Siblings Discordant for Rheumatic Disorders

This study will examine families in which one sibling of a sibling pair, or twin pair, has developed a systemic rheumatic disease and one has not, to see if and how the two differ in the following: * Blood cell metabolism; * Types of cells in the blood; * Environmental exposures or genetic factors that might explain why one developed disease and the other did not. Families in which one sibling has developed a systemic rheumatic disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or myositis, and the other has not, are eligible for this study. The siblings may or may not be twins, but must be of the same gender and be within a 5-year age difference. Biological parents, or, in some cases, children, will also be included in the study. Normal, healthy volunteers will serve as control subjects. Participants will undergo some or all of the following tests and procedures: * Medical history and physical examination. Participants will also be asked permission to obtain medical records for review. * Questionnaires about environmental exposures at work, at home, and elsewhere. Probands (participants with rheumatic disease) and their healthy siblings will also answer questions about infections, vaccinations, medications or dietary supplements, sun exposure, and stressful events during the year before disease diagnosis in the affected sibling. * Blood and urine collection for the following tests: * Routine blood chemistries and other studies to rule out certain diseases or medical problems; * Evidence of past toxic exposures and certain infections; * Presence of cells from the mother in the child s blood and vice versa. (Recent studies suggest that during pregnancy or delivery, cells from the mother and baby may be exchanged and circulate in the body for many years, possibly causing problems); * In twin or sibling pairs, presence of certain genes that may be more common in patients with systematic rheumatic diseases as compared with their unaffected siblings and normal volunteers; * In identical twins, comparison of their blood cell metabolism to see if and how the metabolism differs in people with rheumatic disease. Participants may be asked for permission to have some of their blood and urine samples stored and to obtain previously collected blood or tissue biopsy specimens that are no longer needed for clinical care, for research purposes. They may also be asked to give additional blood or urine samples. Participants will be followed every year for 5 years (either in person or by questionnaire) to evaluate any changes in their condition. The final 5-year evaluation will repeat some of the questionnaires and procedures described above.

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).

INSELMA - a Randomised Controlled Trial

Background: Patients with inflammatory arthritis (IA) experience substantial impact of their disease despite optimal pharmacological treatment. To be able to manage these challenges effectively, patients require tailored self-management support from various professionals. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A pilot study on the INSELMA intervention in 18 participants showed promising results. It is now relevant to test the intervention and compare it to a control group in a larger study . Objectives: The primary objective is to compare the efficacy of the INSELMA intervention to usual care (control group), on health related quality of life measured at baseline and end of intervention (6 months after baseline). Key secondary objectives are to compare the short and longer-term effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, sleep, physical activity, global impact of the disease, work ability, self-efficacy for managing chronic disease and pain and health literacy relative to usual care from baseline to 6 and 12 months after baseline and on quality of life from baseline to 12 months after baseline. Method: A pragmatic randomised trial with a two-group parallel design. All participants will be randomly allocated to the intervention or usual care only . Both groups will receive usual care. The INSELMA intervention group will be assigned a coordinating rheumatology nurse who performs an initial biopsychosocial assessment. Based on the assessment, the nurse and the patient agree on which activities and goals to work towards for the following six months. The coordinating nurse can refer the patient to see a physiotherapist, an occupational therapist or social worker if needed and can help identify offers in the patients' municipality. The primary endpoint will be change in quality of life from baseline to 6 month after baseline. Key secondary outcome measures are collected to compare the effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, self-efficacy for managing pain, physical function, global impact of the disease, sleep problems and acceptable symptoms relative to usual care from baseline to 6 and 12 months after baseline.

Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action

Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)

This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.

Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

Background: \- Orthopedic procedures are common in the United States. These include joint replacement and spine surgeries. Researchers want to study data about these procedures over time. They want to see if treatment has gotten better. They also want to find ways to change the care that people get before and after they have these procedures. These changes may lower the risk of problems people can have during and after treatment. They may also improve people s results. Objectives: \- To study a series of questions about surgery, medicine, treatments, and outcomes for orthopedic procedures. Eligibility: \- Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015. Design: * Researchers will look at data for people ages 20-100. * No new participants will be used in this study. * The study will last 6 years....

An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.

Expanded Access to Upadacitinib

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

MAD Study of IA-14069

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA-14069 in healthy subjects and in patients with RA on stable dosese of MTX, with preliminary assessment of efficacy in RA patients.

Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.

Persona Ti-Nidium Post-Market Clinical Follow-up

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Development and Evaluation of the Effectiveness of the SMART-HAND Protocol for Hand Rehabilitation in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) frequently affects the hand and wrist, resulting in pain, reduced joint stability, impaired proprioception, muscle weakness, and limitations in daily activities. Although conventional rehabilitation primarily focuses on range of motion and strengthening exercises, sensorimotor impairments such as proprioceptive deficits are often underaddressed. The SMART-HAND (Sensory, Massage, Approximation, ROM, Training = Strengthening + Perturbation) protocol was developed as a structured, mechanism-based rehabilitation program to improve proprioception, joint stability, motor control, and hand function. This randomized controlled trial aims to evaluate the effectiveness of the SMART-HAND protocol in individuals with RA by comparing its effects on hand function, proprioception, pain, dexterity, muscle strength, and functional performance with conventional rehabilitation and a control group.

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

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.

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）

A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis

A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.

Phase 1b/2 Study of IV Sarilumab in Adult With RA

This is a Phase 1/Phase 2 study with: * 5-arms design for Part A; * and a single arm for Part B. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be up to 6 months for each study phase. * Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit. * For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits. * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit. * Part B has 13 visits, including a post-treatment EOS follow-up visit.

Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders

The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.

Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

The hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with CIR treated by subcutaneous biotherapies.

Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research

INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs). The primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis. The study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes. The expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.