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URMC / Medicine / Allergy, Immunology, and Rheumatology Research / Funding / Clinical Trials and Clinical Research Funding

 

Clinical Trials and Clinical Research Funding

Research paperwork reviewDivision faculty participate in cutting edge clinical trials of the newest treatments for autoimmune, rheumatic and allergic diseases. In addition to conventional drug studies aimed to improve the efficacy and safety of current therapies, faculty also carry out experimental protocols of particular interest for patients not responding to conventional therapy. Some faculty conduct translational research linking clinical and basic research.

The principal investigators listed below are conducting active clinical trials, clinical research and/or translational research.

  Dr. Anandarah's Profile

Clinical Projects

  • RA CHAMP PLUS: Creating an Integrated Care Model for Patients with Disabilities Secondary to Rheumatic Diseases
    The primary objective of the project is to deliver an integrated and patient-centered service model that provides high-quality care for patients with disabilities secondary to arthritis, from underserved and rural communities, by increasing patient engagement through patient education, promotion of self-management and exercise programs aimed at treatment of arthritis and related heart and bone disease.
  • Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY)
    The TIMELY project aims to overcome the disparities in clinical trial participation by addressing provider and patient reported barriers to enrolling patients in lupus trials, using material developed through prior research efforts.
  • Improve Referral Time to Rheumatology for Patients with Early Inflammatory Arthritis from Underserved and Rural Communities through an Innovative Educational Program
    This patient centered program targets patients with rheumatoid arthritis, especially those in underserved areas. The goals of the program include developing a comprehensive treatment plan for each patient enrolled, decrease co-morbidities, decrease hospitalizations and increase quality of life. (4/2021-12/2022)
  • Improving Care for Patients with Systemic Lupus Erythematosus at High Risk for Admission: The IQ-LUPUS Project (Improve Quality in Low-income, Underserved, Poor, Underage, SLE patients)
    The purpose of this project is to improve health care for lupus patients by improving access to care and adherence to medication use, identifying and modifying behavioral and social impediments to on-going care and to provide an increased awareness of lupus in patients and the community.

Clinical Trials

  • A Phase III, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluated the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
    Sponsor: Samumed; NCT04385303
    Status: CLOSED
  • A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy & Safety of Apremilast (CC-10004) in Subjects with Early Oligoarticular Psoriatic Arthritis
    Sponsor: Celgene; NCT03747939
    Status: CLOSED
  • PSA003 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Two Doses Of Apremilast (CC-10004) In Subjects With Active Psoriatic Arthritis
    Sponsor: Celgene Corporation; NCT01307423
    Status: CLOSED

 Dr. Anoliks' Profile

  • A Multicenter, Randomized Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIBO59 in Adult Participants with Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
    Sponsor: BIOGEN
    Status: ENROLLING
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
    Sponsor: F. Hoffmann-LaRoche Ltd; NCT4221477
    Status: ACTIVE BUT NOT ENROLLING
  • B Cell Tolerance Mechanisms in Human SLE
    Status: ENROLLING
  • Med/AIR Subject Database and Tissue Repository
    Sponsor: Investigator Initiated
    Status: ENROLLING
  • AMP Collaboration: Cellular Dynamics at the Synovium Bone Interface in Rheumatoid Arthritis
    Sponsor: NIH
    Status: ENROLLING
  • Medimmune Collaboration in Primary Sjogren's Syndrome
    Sponsor: Medimmune; 49798
    Status: ACTIVE BUT NOT ENROLLING
  • Autoimmunity Patient Cohort
    Sponsor: Autoimmunity Cohort; 13564
    Status: ACTIVE BUT NOT ENROLLING
  • B Cell Homeostasis in Common Variable Immunodeficiency
    Sponsor: Investigator Initiated; 31076
    Status: ACTIVE BUT NOT ENROLLING
  • A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Clinical Benefit after 24 weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids from krill), Followed by a 24 Week Open-Label Extension, in Patients with Systemic Lupus Erythematosus (SLE)
    Sponsor: Aker Biomarine Antarctic AS; NCT0362631
    Status: CLOSED
  • SSLEDerm- A Pilot Phase 2 R, PC, DB, Study to Evaluate the S&E, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 in Subjects with Systemic Lupus Erythematosus
    Sponsor: Celgene Corporation; NCT02185040
    Status: CLOSED
  • ARA06 A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis
    Sponsor: NIH; NCT00837434
    Status: CLOSED

  Dr. Bingemann's Profile

  • A 52-week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy
    Sponsor: Novartis; NCT04984876
    Status: ENROLLING

 Dr. Korman's Profile

  • Scleroderma Registry
    Sponsor: RSRB 71768 (unfunded)
    Status: ENROLLING

  Dr. Looney's Profile

  • A Prospective Registry to Study Presentation, Clinical Course, Treatment Patterns, and Outcomes in Patients with Systemic Lupus Erythematosus
    Sponsor: RSRB 71768 (unfunded)
    Status: CLOSED
  • Evaluation of Immunocompetency (Gastrointestinal Dysregulation and Systemic Inflammation in Common Variable Immune Deficiency)
    Sponsor: ACAAI; 64705
    Status: CLOSED
  • Old Order Mennonites: Effect of Lifestyle on Allergic and Autoimmune Diseases: Role of the Gut Microbiome in Preventing Allergic Disease
    Sponsor: Env HS CTSI
    Status: CLOSED
  • ALE06-An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE) in Patients with Stable, Quiescent Systemic Lupus
    Sponsor:  NIH NIAID; NCT01946880
    Status: CLOSED
  • Old Order Mennonites: Effect of Lifestyle on Allergic and Autoimmune Diseases
    Status: CLOSED

  Dr. Palma's Profile

  • Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study (SUPERNOVA)
    Sponsor: Astra Zeneca
    Status: ACTIVE BUT NOT ENROLLING
  • Booster Effects with Autoimmune Treatments in Patients with Poor Response to Initial COVID-19 Vaccine COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
    Sponsor: NIAID
    Status: CLOSED
  • A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment
    Sponsor: AbbVie
    Status: CLOSED
  • Immune Modulators for Treating COVID-19 (ACTIV-1 IM)
    NCT04593940
    Status: CLOSED
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants with COVID-19 Associated ARDS who Require Mechanical Ventilation
    Sponsor: Incyte Corporation; NCT04377620
    Status: CLOSED
  • A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19
    Sponsor: Regeneron; NCT04425629
    Status: CLOSED
  • A Study to Evaluate the Safety and Efficacy of Upadacitnib in Participants with Giant Cell Arteritis (SELECT-GCA)
    Sponsor: Abbvie; NCT03725202
    Status: ENROLLING
  • A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Investigate the Safety and Efficacy of Two Different Dose Regimens of IFX-1 as Add-on to Standard of Care in Subjects TH Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
    Sponsor: InflaRx; NCT03712345
    Status: CLOSED

  Dr. Ritchlin's Profile

  • A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease Modifying Anti-Rheumatic Drugs or had Previously Received TNFα Inhibitor Treatment
    Sponsor: BMS
    Status: ACTIVE BUT NOT ENROLLING
  • A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants with Active Psoriatic Arthritis
    Sponsor: Janssen
    Status: ENROLLING
  • Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Stage II Pilot
    Sponsor: NIH
    Status: ENROLLING
  • A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 weeks with Placebo and to Assess Safety and Tolerability Up to 52 Weeks in Subjects with Active Psoriatic Arthritis
    Sponsor: Novartis; NCT04209205
    Status: CLOSED
  • DC-STAMP: Regulators of Osteoclastogenesis and Response Marker in PsA
    Sponsor: NIH; NCT03011242
    Status: CLOSED
  • A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis
    Sponsor: UCB; NCT03896581
    Status: CLOSED
  • Susceptibility Factors for Arthritis in Patients with Psoriasis
    Sponsor: UCB (IPART Registry)
    Status: CLOSED
  • Predicting Psoriatic Arthritis Onset: Skin Biopsy Use as Prognosticator
    Status: ENROLLING
  • Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green
    Sponsor: NIH; NCT02680067
    Status: ENROLLING
  • A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
    Sponsor: UCB Biopharma; NCT03347110
    Status: ACTIVE BUT NOT ENROLLING
  • Incubator: DC-STAMP and TRAF3: Regulators of Osteoclastogenesis and Biomarkers in Psoriatic Arthritis
    Sponsor: CTSI; NCT02413749
    Status: CLOSED
  • Serum, Cellular and Imaging Markers of Arthritis in Psoriasis Patients
    Sponsor: RRF; NCT02413801
    Status: CLOSED
  • Corrona data collection program
    Sponsor: Corrona; NCT02530268
    Status: CLOSED
  • BIODAM Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis
    Sponsor: CaRE; NCT01476956
    Status: CLOSED
  • Imaging and Cellular Markers of Arthritis in Psoriasis Patients
    Sponsor:  Amgen
    Status:  CLOSED
  • CORRONA Spondyloarthritis and Psoriatic Arthritis (SpA/PsA) Registry
    Sponsor:  Corrona; NCT02530268
    Status:  CLOSED
  • A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)
    Sponsor:  Bristol-Meyers Squibb; NCT03881059
    Status: CLOSED
  • SEAM: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
    Sponsor:  Amgen; NCT02376790
    Status: CLOSED
  • AMVISION-2: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis
    Sponsor:  Amgen; NCT02029495
    Status: CLOSED
  • AMG827: A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis
    Sponsor:  Amgen; NCT02707341
    Status: CLOSED
  • TRAF3 levels in Blood Monocytes in Rheumatoid Arthritis
    Sponsor:  CTSI
    Status: CLOSED

  Dr. Shah's Profile

  • Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)
    Sponsor: NIH; NCT02633163
    Status: CLOSED
  • Pilot Trial of Ustekinumab for Primary Sjögren’s Syndrome
    Sponsor: Janssen; NCT04093531
    Status: CLOSED
  • A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis
    Sponsor: Kezar Life Sciences; NCT03393013
    Status: CLOSED

  Dr. Tabechian's Profile

  • Musculoskeletal Ultrasound
    Sponsor: None; 14883
    Status: CLOSED