Clinical Trials and Clinical Research Funding
Clinical Trials and Clinical Research Funding
Division 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.
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
- 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
- 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: CLOSED
- Scleroderma Registry
Sponsor: RSRB 71768 (unfunded)
Status: ENROLLING
- 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
- 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
- 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
- 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
- Musculoskeletal Ultrasound
Sponsor: None; 14883
Status: CLOSED