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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

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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Healthy Control Esophageal Registry and Biorepository

This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.…
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology
- Have a diagnosis of an eating disorder
- Have a diagnosis of an autoimmune disease
- A current or previous smoker (smoked >100 cigarettes in lifetime)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Taking antacids and/or proton pump inhibitors for heartburn
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
Carlson, Dustin AllanCarlson, Dustin Allan
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00096856
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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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    Large Vessel Vasculitis Tissue Registry and Repository (LVVRR)

    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become …
    The purpose of this study is to investigate the roles that specific cells in the immune system and their signals play in large vessel vasculitis (giant cell arteritis, GCA). In large vessel vasculitis, blood vessels such as the temporal arteries that run along the sides of the head can become inflamed, commonly causing headaches, joint pain, facial pain, fever, and difficulties with vision.

    We will study the gene expression (i.e., the genes that are being "read" to make proteins) in these immune cells, with a special focus on macrophages (one type of cell in the immune system). We will compare the gene expression in patients with vasculitis to the gene expression in people without vasculitis to determine what goes wrong in patients with this condition. If we can identify the molecular pathways that are affected in vasculitis, we can begin to develop treatments that will target these pathways. This may help us predict which patients will respond to treatment in the future.

    Patients who participate in this research will:

    • Complete a screening and demographic form
    • Complete questionnaires
    • Give 2 tubes of blood
    • Donate a portion of the left-over biopsy tissue taken during your standard of care temporal artery biopsy procedure

    Participants will be given a stipend after the samples (blood and biopsy) have been collected.

    For Vasculitis Patients:

    • Suspected large vessel vasculitis - meet two of the giant cell arteritis (GCA) criteria, one of which is onset at age 50 or older
    • Planning to undergo a temporal artery biopsy

    For Controls:

    • Undergoing intracranial surgery from temporal approach for reasons unrelated to inflammatory autoimmune disease

    Dua, Anisha BharadwajDua, Anisha Bharadwaj
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00210635
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    CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

    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 Paivlion
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211593
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    Sleep Fragmentation, Autonomic Dysfunction, and Centralized Pain in Rheumatoid Arthritis

    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative …
    This study is looking at the relationship between sleep and pain in patients with RA. The goal of the study is to learn how toprevent the development of chronic pain in RA in the future. The study involves one study visit at thedowntown campus at Northwestern, completing questionnaires, undergoing quantitative sensory testing, wearing a wristmonitor (similar in size and appearance to a digital watch) to collectinformation about participant's sleep patterns, and wearing a patch to measureheart rate for about two weeks. Participantsare paid $50 for their time and effort.
    Participants must be 18 years or older and English-speaking with a confirmed diagnosis of Rheumatoid Arthritis. Participants cannot be taking beta blockers, certain pain medications, sedatives, or more than 10 mg of prednisone daily. Participants cannot have a history of heart conditions or work night shifts.
    Lee, Yvonne ClaireLee, Yvonne Claire
    • Map it 633 N. St. Clair St.
      Chicago, IL
    STU00211633
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    A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients with Diffuse Cutaneous Systemic Sclerosis

    This trial is testing an experimental drug called EHP-101, which has already been tested in a small group of healthy participants in a research study conducted in Australia. It is now being tested for the first time in patients with diffuse cutaneous systemic sclerosis (dcSSc). This study drug has …
    This trial is testing an experimental drug called EHP-101, which has already been tested in a small group of healthy participants in a research study conducted in Australia. It is now being tested for the first time in patients with diffuse cutaneous systemic sclerosis (dcSSc). This study drug has not been approved by Regulatory Authorities such as the Food and Drug Administration in the United States or anywhere in the world. The aim of this research is to determine the safety of the study drug when delivered by multiple oral (by mouth) doses to individuals with dcSSc for up to 84 days. the study will also look at how well tolerated the study drug is and what effects it has on the body and how effective the study drug is and how long it is effective.

    Participants will be in the study for about 5 months and complete the following:

    • Assigned to one of four groups:
  • Cohort 1 - 25 mg once per day of either active drug or placebo
  • Cohort 2 - 25 mg twice per day of either active drug or placebo
  • Cohort 3 - 50 mg once per day of either active drug or placebo
  • Cohort 4 - 50 mg twice per day of either active drug or placebo
    • Within each group, the participant will be randomly assigned to receive active study drug or placebo (which looks like the study drug but contains no actual medication). Participants will be twice as likely to receive the active study drug as the placebo.
    • Attend 10 study visits, which may include a physical exam, vitals, test of the heart, blood tests, urine pregnancy test, eye exam, skin biopsies, and questionnaires.
    Participants will receive a stipend after each completed study visit.

    • Between 18 and 74 years old
    • Meet criteria for diffuse cutaneous systemic sclerosis (dcSSc)
    • Disease duration of 6 years or less
    • Skin score of at least 15
    • If taking immunosuppressants (such as mycophenolate, methotrexate, etc.) must be on a stable dose for at least 3 months
    • If taking prednisone, must be on a stable dose for at least 1 month and taking 10 mg or less
    • Females with childbearing potential must use a highly effect method of birth control throughout study and for at least 28 days after the last dose of study treatment
    • Males with female partners of childbearing potential must use an acceptable contraception method throughout the study and for 90 days after the last dose of study treatment and refrain from donating sperm during this period
    • Additional exclusion criteria apply
    Richardson, CarrieRichardson, Carrie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04166552 STU00213693
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    KD025-215: A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects with Diffuse Cutaneous Systemic Sclerosis (dcSSc)

    This trial is testing whether belumosudil (KD025), the study drug, is safe and effective for patients with diffuse cutaneous systemic sclerosis (dcSSc). The study drug is "investigational" because it is not approved by the United States Food and Drug Administration (FDA) to treat any disease. It may be an effective …
    This trial is testing whether belumosudil (KD025), the study drug, is safe and effective for patients with diffuse cutaneous systemic sclerosis (dcSSc). The study drug is "investigational" because it is not approved by the United States Food and Drug Administration (FDA) to treat any disease. It may be an effective therapy for conditions such as skin thickening or lung disease.

    Participants in this study will participate for up to 60 weeks:

    • Receive the study drug 200 mg twice daily by mouth for 52 weeks
    • Complete study visits every two weeks for the first month and then monthly thereafter
    • During study visits, will have physical exam, blood and urine tests, tests of the heart and lungs, and complete questionnaires
    • Complete skin biopsies (two on the forearm) at three study visits

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

    • At least 18 years old
    • Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc)
    • Disease duration of 6 years or less
    • Active disease per the treating physician
    • Skin score of at least 15 and up to 40
    • Additional exclusion criteria apply

    Richardson, CarrieRichardson, Carrie
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    • Map it 633 N. St. Clair St.
      Chicago, IL
    NCT04680975 STU00213748
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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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