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Rheumatology Clinical Trials

The following searchable list includes all the Division of Rheumatology - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials

Northwestern Scleroderma Program Registry

The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn …
The Scleroderma Patient Registry collects clinical information and biological samples for patients seen at the Northwestern Scleroderma Program (NSP). The information collected is used for studies designed to increase our understanding about the course of the disease and the care and outcomes of scleroderma patients. Researchers conduct studies to learn more about scleroderma, understand why the skin and other internal organs become thickened and hardened (fibrotic) in people with scleroderma, and determine what therapies are effective for treating scleroderma. The registry also allows us to identify possible patients for future studies related to scleroderma. There are five optional components of the Registry: completion of health questionnaires, skin biopsies at two different time points, annual blood collection, and participation in NUgene.
Patients ≥18 years old with a diagnosis of scleroderma (including all sub-types of disease) as defined by American College of Rheumatology criteria or scleroderma mimic disorder, localized scleroderma, or very early diagnosis of systemic sclerosis (VEDOSS), per physician assessment.
Richardson, CarrieRichardson, Carrie
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00002669
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Chicago Lupus Database

Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us …
Establishing in 1991 and maintained by Northwestern University, the Chicago Lupus Database (CLD) is a registry of individuals with lupus who are willing to be contacted about future lupus research studies for which they might be eligible. Participants can enroll in any number of research studies designed to help us learn more about lupus.
Men and women 18 years or older with either a probable or definite lupus diagnosis can sign up for the Chicago Lupus Database.
Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00009193
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Synovial Macrophage Transcriptional Signatures for Predicting Therapeutic Efficacy

We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, …
We know that in rheumatoid arthritis (RA), considerable thickening of the lining layer (synovium) in the joints occurs. This represents the accumulation of new cells and tissue. We would like to learn more about what contributes to the disease progression of RA and why some people respond to RA therapy, while others do not. To do this, we will examine the cells, genetic material, proteins and other features in the tissue from the inflamed joints and blood of patients with RA. We hope that by studying this tissue and blood, we may learn information that may help lead to the development of new treatments for this disease.
• Diagnosis of rheumatoid arthritis (RA).
• Must have been 18 years of age or older at the time of diagnosis of RA.
• At least one swollen joint (elbow, writs, knee, ankle, or shoulder) due to active RA.
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00104822
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LIFT: Lupus Intervention for Fatigue Trial

This study is designed to evaluate the effectiveness of one-on-one counseling sessions on reducing symptoms of fatigue in persons with lupus by providing them with individualized coaching on increasing physical activity and improving diet.
Have lupus and experience fatigue as a result.

At least 18 years old.

Can participate in physical activity.

Live in the Chicago area.

Be able to speak and read English.

Be able to consent to being in the study.

Ramsey-Goldman, RosalindRamsey-Goldman, Rosalind
  • Map it 633 N. St. Clair St.
    Chicago, IL
NCT02653287 STU00201960
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Vasculitis Clinical Research Consortium (VCRC) Genetic Repository One Time DNA Protocol

The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms …
The study is being done to identify genes that increase the risk of developing vasculitis. The purpose of the study is to: Collect clinical data and genetic information (DNA) on patients with vasculitis; Discover genetic markers that increase the risk of developing vasculitis; Discover genetic markers linked with certain symptoms of vasculitis. The study involves donating one tube of blood for the collection of genetic information (DNA) at one study visit.
- Giant Cell Arteritis- Takayasu’s Arteritis - Polyarteritis Nodosa - Granulomatosis with Polyangiitis (Wegener’s) - Microscopic Polyangiitis - Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)
Dua, Anisha BharadwajDua, Anisha Bharadwaj
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00206908
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Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

Patients who participate in this study will:

  • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
  • give a blood sample
  • give esophageal biopsies (taken during their scheduled endoscopy)
  • as an option, give skin biopsies

  • At least 18 years old
  • Meet criteria for systemic sclerosis
  • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
  • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00207083
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The Collaborative, National Quality and Efficacy Registry (CONQUER)

The CONQUER Registry will enable researchers to:Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waitingEvaluate the response in the real world (…

The CONQUER Registry will enable researchers to:

  • Determine whether certain disease features are associated with or predict clinical and patient-reported outcomes (short-term and long-term).
    • Identify which patients require early and aggressive intervention and which patients are better suited for “watchful waiting
  • Evaluate the response in the real world (as opposed to the controlled and constrained setting of a clinical trial) to therapeutic agents and to combinations of therapeutic agents.
    • Drive more personalized and effective therapy for patients
    • Develop insights into drug toxicities that are unique to scleroderma patients (e.g. underlying heart disease due to pulmonary vascular disease)
    • Understanding patient satisfaction/issues with the current Standard of Care
  • Collect biosamples for future analyses (e.g. genetic factors contributing to disease)
  • Establish and support a collaborative network for U.S. scleroderma investigators
  • Support the critical infrastructure for future scleroderma studies, including trials for novel therapeutics
  • Patients must:

    1. Be 18 years of age and older

    2. Have a confirmed diagnosis of systemic sclerosis (meeting the 2013 SSc ACR/EULAR criteria)

    3. Have had symptoms of SSc for less than 5 years (other than Raynauds - it is okay if this has been going on for greater than 5 years)

    Richardson, CarrieRichardson, Carrie
    • Map it 633 N. St. Clair St.
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00207506
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    CPIRA-2

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors that lead to the development of pain centralization, so that in future studies we can learn more about how to prevent the development of this kind of chronic pain in RA.

    Participants will complete a total of 3 study visits (baseline, 3 months and 12 months). At each study visit, participants will have a physical exam, have blood drawn, answer questionnaires, and undergo quantitative sensory testing to assess responses to pressure and coldness. A subset of patients who are interested and eligible will undergo a brain MRI at baseline and the 12-month study visit. Participants will receive $50 for the completion of each study visit and an additional $100 for completing each MRI.

    Study participants must be 18 years or older with active Rheumatoid Arthritis and symptoms starting no more than one year prior to study participation.  Participants taking pain medications must be on a stable dose for at least 3 months.  Patients with Raynauds requiring treatment are not eligible to participate.  Participants must refrain from taking prednisone (greater than 10 mg) or opioids within 24 hours of their study visit.  
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 710 N. Fairbanks Ct. Olson Pavilion
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211593
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    NP-SLE

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what …

    This study will examine different proteins and cell types in blood and cerebrospinal fluid (CSF) of patients with systemic lupus (SLE) who may or may not currently be experiencing neuropsychiatric manifestations of the disease. We aim to identify specific factors that affect the regulation of genes to help explain what goes wrong in systemic lupus. Then, we hope to develop treatments that will target these factors.

    Inclusion Criteria:

    • Meet 4 of 11 American College of Rheumatology (ACR) criteria for systemic lupus (SLE) or meet 3 of 11 ACR criteria for SLE and meet SLICC criteria
    • 18 years or older
    • Positive ANA or positive dsDNA

    Exclusion Criteria:

    • Currently pregnant or nursing
    • Active or chronic infections (such as hepatitis, pneumonia, pyelonephritis, HIV, sepsis)
    • Diagnosed with another chronic autoimmune disease or chronic neurodegenerative condition
    • CKD > 2 and/or GFR < 60
    • AST and/or ALT ≥ 3 times the upper limit of normal
    • Current electrolyte disturbance (hyponatremia or hypernatremia)
    • Current signs or symptoms of acute systemic vascultis
    Cuda, Carla MarieCuda, Carla Marie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00211615
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    NAV3-32: A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)

    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by …
    This trial is being done to determine the ability of technetium Tc 99m tilmanocept (study drug) to find inflammatory cells in the joints of patients with rheumatoid arthritis (RA) via imaging. The imaging results will also be compared to the different types of cells present in the joints affected by RA. The goal is to determine if imaging can be used to better characterize inflammation for rheumatoid arthritis patients, which may be helpful in diagnosing and treating patients.

    Patients who participate will attend 3 clinic visits and 2 phone calls over 45 days and will complete the following:

    • Receive an investigational drug one time through an IV in the arm
    • Have pictures taken of their hands and wrists to look at the inflammatory cells in the joints
    • Have a physical exam
    • Undergo an ultrasound of their hands and wrists
    • Have a synovial (joint) tissue biopsy of the hand or wrist
    • Give blood and urine samples
    • Answer questions about their RA and health

    A stipend will be offered to participants for each completed study visit.

    • Meet criteria for rheumatoid arthritis (RA) and have active disease.
    • At least 18 years of age or older at the time of RA diagnosis.
    • Hand or wrist joint with swelling.
    • Use adequate birth control measures for the duration of the study.
    • If receiving traditional DMARDs, must be on therapy for at least 90 days and at a stable dose for at least 30 days.
    • If receiving biologic DMARDs, must be on a stable dose for at least 60 days.
    • If receiving NSAIDS or steroids, must be on a stable dose for at least 28 days and not be receiving more than 10 mg prednisone per day.
    • Additional exclusion criteria apply.
    Ruderman, Eric MRuderman, Eric M
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04078191 STU00213603
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    IMPACT-Pain-RA

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. People living with RA commonly report persisting pain which on average is 30% more intense than the general population. Previous research has found that this ongoing pain may in part be …

    Finding a way to reduce pain is consistently named as one of the top priorities for patients with RA. People living with RA commonly report persisting pain which on average is 30% more intense than the general population. Previous research has found that this ongoing pain may in part be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will examine the relationship between immune cells (cells that are part of the immune system, that help the body fight infections and other diseases) and pain centralization. This study will also search for biomarkers (substances that can be measured in the blood) that may be associated with pain centralization, so that we can determine who may be at at risk for developing this kind of chronic pain and how to treat and/or prevent it in the future.

    Participants will be in this research study for one study visit, lasting about 2 hours. Participants will undergo a physical examination to assess joint inflammation, complete questionnaires, undergo quantitative sensory testing (QST) assessments, and provide blood samples.

    Key Criteria:

    • Meet the ACR/EULAR 1987 or 2010 criteria for RA
    • On a DMARD for RA
    • Swollen joint count ≤ 1
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00215712
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    PROMOTER

    Finding a way to reduce pain is consistently named one of the top priorities for patients with RA. People living with RA commonly report persisting pain which, on average, is 30% more intense than the general population. Previous research has found that this ongoing pain may, in part, be caused …

    Finding a way to reduce pain is consistently named one of the top priorities for patients with RA. People living with RA commonly report persisting pain which, on average, is 30% more intense than the general population. Previous research has found that this ongoing pain may, in part, be caused by problems in the way the brain processes pain signals. This is called pain centralization. This study will identify factors associated with pain centralization, so that, in future studies, we can learn more about how to prevent the development of chronic pain in RA. This study will also identify biomarkers that could provide insight into targeted therapies for future clinical trials.

    This study includes two in-person study visit to complete quantitative sensory testing (QST), blood draws, joint counts, blood pressure assessment, and patient-reported outcome (PRO) questionnaires. If participants are unsure of their height and/or weight off-at the time of the visits, they may also have height and/or weight assessed. The first visit will occur at baseline within 3 weeks of the patient starting their DMARD. The second visit will occur 12 weeks (+/- 3 weeks) after starting their new DMARD.

    Key Eligibility Criteria

    • Have had at least one joint with definite swelling
    • Meet the ACR/EULAR 1987 or 2010 criteria for RA
    • Starting a DMARD for treatment of active RA
    Lee, Yvonne ClaireLee, Yvonne Claire
    STU00216431
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    RESET-RA

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).…

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).

    Inclusion Criteria:

    • 22-75 years of age at screening
    • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
    • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
    • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

    Exclusion Criteria:

    • Untreated or poorly controlled psychiatric illness or history of substance abuse
    • Significant immunodeficiency due to underlying illness
    • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
    • Clinically significant cardiovascular disease
    • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
    • Uncontrolled fibromyalgia
    • History of left or right carotid surgery
    • History of unilateral or bilateral vagotomy, partial or complete splenectomy
    • Recurrent vasovagal syncope episodes
    • Current, regular use of tobacco products
    Ruderman, Eric MRuderman, Eric M
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    NCT04539964 STU00213547
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    Molecular Biomarkers to Guide Therapy in the Systemic Sclerosis-Associated Interstitial Lung Disease

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we …

    The purpose of this study is to better understand the development and progression of scleroderma-related lung fibrosis (SSc-ILD). We would like to find indicators (biomarkers) that can help us predict which patients will develop SSc-ILD and who might benefit from receiving certain treatments. To do this, we will collect and study your clinical and imaging data and samples (blood, lung fluid, and skin) if you agree to participate in this research.

    SSc Patients

    Inclusion Criteria:

    • Age 18 or older
    • Receiving clinical care at Northwestern Medicine
    • Meet 2013 ACR criteria for diagnosis of SSc

    Exclusion Criteria:

    • Unable to provide informed consent
    • Diagnosis of an overlap syndrome (i.e., SLE, RA, etc.) that is considered clinically significant by the investigators
    • Currently pregnant or nursing
    • Contraindication to the bronchoscopy per the pulmonologist

    Healthy Controls

    Inclusion Criteria:

    • Age 18 or older
    • Not diagnosed with a rheumatic autoimmune disease (i.e., lupus (SLE), rheumatoid arthritis (RA), etc.)

    Exclusion Criteria:

    • Unable to provide informed consent
    • Currently pregnant or nursing
    • Current smoker or former smoker (> 10 pack years)
    • Lung disease, uncontrolled congestive heart failure, cancer or history of cancer, HIV, or chronic liver disease
    • Contraindication to the bronchoscopy per the pulmonologist
    Misharin, AlexanderMisharin, Alexander
    • Map it 675 N. Saint Clair St. Eighteenth Floor, Suite 250
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    STU00218939
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