Clinical Trials

Participants agree to allow the collection of information from the medical record for research purposes and agree to allow us to contact them about future studies. Participants may also complete questionnaires during their standard of care visits, participate in an optional frailty study by taking a brief physical ability test at the time of standard of care visits, give optional blood for research, and optionally allow us to contact them about their health on an annual basis.

1 year, 2 visits.

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

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.

This research study involves the use of Magnetic Resonance Imaging (MRI) to study the effects

of COVID-19 on the heart. Since COVID-19 is a new disease, we do not yet understand the

different ways that it may effect the body. There is some evidence that individuals with COVID-

19 are at higher risk for heart complications. The purpose of this study is to use recently

developed MRI techniques to compare heart health of individuals with COVID-19 to people who

were asymptomatic or are healthy. The new MRI techniques used in this experiment may also allow researchers and health care providers to take clearer pictures of the heart in other

individuals.

For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart).

Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the leaflets of the mitral valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart needs to pump more blood with each beat to push the same amount of blood forward.

The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.

To develop new MRI approaches that can better quantify the severity of left atrial fibrosis, for the purposes of predicting whether patients will revert to atrial fibrillation (AF) following an initial successful procedure

Prospective, single arm, multi-center, early feasibility study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Normally, white blood cells are produced in a controlled way by the bone marrow. In someone with AML or ALL, this production process is abnormal and immature cells are produced and sent into the blood stream. In this immature state, the cells affect the production of other normal cells and these cannot perform their usual functions. Therefore patients with AML or ALL are vulnerable to infection, anemia, and bleeding.

The purpose of this study is to understand what causes the white blood cells to grow abnormally, and to determine if there are novel agents that can be used to stop this abnormal growth. In this research project, a sample of blood and bone marrow will be studied in the laboratory to learn more about the nature of the disease, and to understand what causes the defect in the growth of these cells.

The purpose of this research study is to examine many aspects of gastrointestinal disease including pancreatic and colon cancer, including its genetics, its early stages, and the effects of cancer on other tissues such as muscle and adipose (fat) tissue. Tissues from patients (with cancer as well as from those without), who are undergoing pancreatic surgery, will be used in this research.

In this research project, samples of blood and bone marrow will be studied in the laboratory to learn more about the nature of chronic myelogenous leukemia (CML) cells and how various medications and chemical agents affect them.

The purpose of this study is to learn about how CML leukemia cells become resistant to medications or progress to acute leukemia (blast crisis). This may prove to be helpful in the design of new more effective drugs for the treatment of CML in the future.

In this research study, samples of bone marrow or peripheral blood will be collected from patients with chronic myeloid leukemia (CML) to learn more about the effect of some new drugs on CML cells in the laboratory. The purpose of this study is to understand how these new drugs stop leukemia cells from growing. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

The Northwestern Brain Tumor Institute (NBTI) currently uses an electronic database to collect and store information about patients who come to the NBTI for evaluations, including diagnosis, treatment, follow-up, and/or to obtain additional opinions. This database is called the Northwestern Brain Tumor Institute Database or NBTIDB, and it was developed to replace older paper methods for collecting and storing information.

The purpose of this study is to allow researchers involved with the NBTIDB to use data stored in it for future research studies and projects. The NBTIDB also allows researchers to track whether or not patients have agreed to allow their information to be linked to their leftover tissue samples, which are kept in the hospital’s pathology department, for future research studies.

Researchers have found that about 60% of patients with acute myeloid leukemia (AML) will obtain a remission following treatment with combinations of chemotherapy drugs. However, relapse after treatment remains a problem, and can be as high as 80% in some types of AML patients. Therefore, it would be beneficial to identify specific treatment approaches for patients at a high risk for relapse. One characteristic associated with high relapse rates is an increase in proteins that are referred to as Hox proteins in the leukemia cells. Increase in Hox proteins prevents production of some other proteins, including a protein referred to as Triad1. An increase in Triad1 protein in bone marrow cells may be important to control the growth of such cells. Decreased Triad1 in leukemia cells may therefore promote their growth, but this has not been previously studied.

The purpose of this study is to investigate if the lack of Triad1 in leukemia cells contributes to resistance of some leukemias to chemotherapy drugs. This research may prove to be helpful in the design of new and more effective treatments for leukemia in the future.

At a time when you are having a bone marrow biopsy and aspirate performed as part of your standard medical care, about an additional 2.5 teaspoons (12.5 mL) of bone marrow will be collected for this research study.

Researchers would like to create a bio-specimen bank of tissue, blood, urine and saliva, which would then be used to study cancer and find better ways to detect, prevent, diagnose, treat and provide better care for future patients. Some of these studies may be about how genes affect the development of cancer, response or resistance to treatment as well as prognosis (course of disease and overall outcome including survival). Other studies may aim to identify measurable substances in the blood and/or urine (known as biomarkers) that can indicate early development of cancer, worsening or relapse of disease and response to treatment. Some studies may lead to new products, such as drugs or tests for detection of cancer.

The purpose of this registry is to collect clinical information on all consenting head and neck cancer patients seen at the Northwestern Medical Group (NMG) or Northwestern Memorial Hospital (NMH). With this information, researchers will conduct studies to learn more about the subtypes of head and neck cancers and determine the most effective treatments. The registry will also allow us to identify possible subjects for future studies.

This study is being done to help improve the knowledge on the biology of breast cancer in the future. Blood specimens from patients with breast cancer will be collected and utilized for future research projects known as biomarker studies. These blood based laboratory tests will ultimately evaluate molecules present in the blood of patients with breast cancer. These molecules could be, for example, a protein, tumor DNA, or tumor cells circulating in the blood. As research technology advances, blood samples from patients with breast cancer may help in understanding the course of disease and to check as to how effective a treatment is.

The purpose of the study is to gather information about your cancer and the treatment you receive as a part of your routine clinical care. In this study, we are developing a research registry, which is a bank of information about many patients.

We are interested in learning about the relationship between your cancer and the different types of tests available to identify the best treatment option for you. That is, we are interested in the tests that identify possible ‘mutations’ (e.g., changes) or ‘drivers’ within your tumor, what treatments you receive after getting these tests, and how your cancer responds to the treatments.

The tests known as next generation sequencing or “NGS” are usually done on your cancer tissue or blood samples as a part of your routine clinical care. Your doctor can use the information to identify the best treatment option for you after discussing it with other doctors. These routine tests will be performed whether you participate in this study or not, but we want to collect the information about this process for this study.

If you participate in this study, extra samples of your blood will be collected and stored, and your health information from your medical record and NGS lab results will be collected and stored.

The purpose of this study is to allow researchers studying and treating melanoma and other cancers to have access to tissue for research purposes only. Northwestern University may use your medical record information, as well as tumor, blood, saliva, urine, and fecal samples (collectively called “tissue”) for research studies to help us understand melanoma and other skin cancers. Biopsies and surgery of your cancer will not be a part of this study but will be performed as part of your standard care.

The purpose of this research is to determine whether radiotherapy after surgery to remove a breast cancer can help decrease the number of circulating tumor cells (CTCs) in the blood. Circulating tumor cells are cancer cells that are shed from the tumor into the blood stream and are believed to be one of the first indicators that breast cancer cells may remain after surgery. Approximately 20% of women with early-stage breast cancer can be found to have CTCs in a small sample of blood taken several weeks after surgery. Radiotherapy is used after surgery to remove a breast cancer in order to sterilize any cancer cells that may be remaining in the breast. It is not known if radiotherapy can help decrease or eliminate CTCs that are found in the blood. This study aims to find out if testing for CTCs can be clinically useful for guiding radiotherapy treatment decisions. Another aim of this study is to evaluate whether CTCs can be used to measure the effectiveness of radiotherapy in an individual patient.

The purpose of this study is to compare the usual treatment alone

to using PET/CT imaging to look for cancer that has spread to the pelvis plus the usual treatment.

We want to see if we can provide a more targeted treatment to this type of cancer by treating up to 5

specific lesions that are seen on the PET/CT scan. Part of the purpose of this study is also to see

whether adding apalutamide and directed radiation works better than the usual approach to help treat

prostate cancer that has returned after surgery.

This study will help the study doctors find out if this different approach is better than the usual

approach. To decide if it is better, the study doctors will be looking to see if the study approach

increases the time before cancer growth or if the cancer causes major additional symptoms.

This study has 4 study groups. Participants will be assigned to 1 of 4 possible treatment groups

depending on the results of your PET/CT scan. After you finish your study treatment, your doctor will

continue to follow your condition for up to 10 years and watch you for side effects and monitor the

progression of your cancer.

Group 1 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to outside of the pelvis. You will get the usual appropriate care that is used to treat this type of

cancer, the planned standard of care treatment with radiation therapy (SOC RT) and STAD for 6 months.

Group 2 (Negative for Extra Pelvic-Metastases)

If you are in this group, it means your PET/CT scan did not show evidence that your cancer has spread

to areas outside of the pelvis. You will get a study treatment, planned SOC RT + STAD + apalutamide

for 6 months.

Group 3 (Positive for Extra Pelvic-Metastases)

If you are in this group, it means that your cancer has spread to areas outside of your pelvis.

You will get planned SOC RT + STAD + apalutamide for 6 months.

Group 4 (Positive for Extra Pelvic-Metastases)

If you are in this group, your cancer has spread to areas outside of your pelvis.

You will get a planned SOC RT + STAD + apalutamide for 6 months + directed radiation therapy to

where the cancer has spread. Each patient will undergo another (or additional) PET/CT scan,

which will take place about one year after starting treatment or if clinically necessary at an

earlier time point.

This study is being done to learn how the microbiome evolves through stem cell transplantation, how it can be shaped by socioeconomic status, the neighborhoods that people reside in, and their diet, as well as certain clinical factors (such as antibiotic usage). Study participants will be asked to provide a saliva sample and complete a questionnaire.

Participants 18 years or older who have metastatic melanoma, and the cancer has a change in the gene called the BRAF, and is not responsive to treatment with MEK and BRAF inhibitors will be enrolled.

This study has two phases. Phase 1 and Phase 2.

The purpose of Phase 1 is to test the safety of the study drug, tazemetostat, in combination with the usual treatment, dabrafenib and trametinib. This study tests different doses of tazemetostat with the usual dose of dabrafenib and trametinib to see which dose of tazemetostat is safest for people. Tazmetostatis not approved by the FDA for treatment of this type of cancer.

All people taking part in this study will get the same dose of the usual intervention, dabrafenib and trametinib. However, people in this study will get different doses of the study drug, tazemetostat. Once the highest safe dose is found, phase 1 of the study is stopped.

The purpose of Phase II is to compare the combination of tazemetostat, dabrafenib, and trametinib to tazemetostat alone. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is for the study doctors to learn if a genetic test is helpful to decide if tazemetostat is more effective in patients whose cancer has an abnormal EZH2 gene. The combination of tazemetostat, trametinib, and dabrafenib, has not been administered together in patients and the combination of these agents are not FDA approved for the treatment of this type of cancer.

Participants who take part in this study will either get a combination of usual approach of dabrafenib and trametinib, and the study drug, tazemetostat or will get the study drug, tazemetostat alone, until their disease gets worse or the side effects become too severe.

The purpose of this study is to compare the early treatment(before you have symptoms) of venetoclax and obinutuzumab (V-O) to the usual treatment of V-O after you have symptoms. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. Another purpose of this study is to find out how early V-O treatment affects patients’ physical, social, and emotional well-being, compared to patients receiving the standard delayed V-O treatment.

The antibody, obinutuzumab, and the drug, venetoclax are already approved by the FDA for use in patients with previously untreated CLL or SLL. Most of the time these drugs are not used until a patient has symptoms that make treatment necessary.

Participants who decide to take part in this study will either get treatment with venetoclax and obinutuzumab (V-O) that starts before symptoms start (now), or participants will get treatment with venetoclax and obinutuzumab (V-O) that will start after symptoms start (later). For all patients, the treatment with V-O will continue for 12 months or until the cancer gets worse, or the side effects are too great.

After treatment is finished, participants will be followed for up to 10 years after enrollment.

The purpose of this study is to compare the usual treatment with T-DM1 alone toT-DM1 plus tucatinib. This study will help the study doctors find out if this different approach is better than the usual approach. T-DM1 is already approved by the FDA for use in patients with HER2-positive cancer. Tucatinib has not been FDA-approved to treat breast cancer.

Participants who decide to participate will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe.

After study treatment is finished, the study doctor will follow participants to watch for side effects and for signs of breast cancer returning. This may include a clinic visit every 6 months for 10 years.

The purpose of this study is to examine the good and bad effects of taking the study drug sacituzumab govitecan. This study will help the study doctors to find out if taking the study drug, sacituzumab govitecan will help to decrease cancer in the brain more than usual treatment. The study will also help the study doctors understand if taking the study drug extends the time until the cancer gets worse.

Sacituzumab govitecan is not approved by the FDA for use in patients with HER2-negative breast cancer that has spread to the brain. It is approved for use in patients with metastatic triple negative breast cancer that was previously treated.

Participants who are enrolled into this study will get the usual drugs selected by their study doctor that can help to prevent the side-effects that might be caused by the study drug. Participants will also get the study drug, sacituzumab govitecan, during each cycle. Each cycle lasts 21 days. This study has up to 35 cycles (or approximately 2 years).

As long as the cancer does not get worse and participants do not experience severe side effects, and their study doctor determines that it is beneficial for them to remain on study, they will continue to get the study drug until completion of the study.

The purpose of this study is to assess if the use of a 3D imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room for breast conservation surgery.

If you are undergoing breast conservation surgery and meet all criteria, the 3D imaging device, VSI, will be used to guide and assist the surgeon in identifying and removing all positive margins while in the operating room. The lumpectomy procedure will be performed per standard practice.

If eligible, the lumpectomy procedure will be performed per standard practice. Promptly after excision, the tumor specimen will be imaged using the VSI device to take additional 3D images of the removed tissue during the standard of care surgery.

During surgery, after the tumor has been removed, the investigators will use the VSI device to identify the margins on the main sample. The surgeon will use this information to remove additional tissue from the cavity. The surgeon will then complete the standard of care surgery according to standard of care practices which may include additional shaves of the remaining issue. The amount of tissue removed as a result of VSI-directed shaving will not be more than the amount that your surgeon would normally remove as part of standard of care.

Participants will be asked to come for a post-operative visit as per standard of care and will be followed-up up to 2 months after surgery.

Note: This is only a partial description of the study procedures. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

This study is being done to collect, process, and store blood samples of plasma cell disorder patients. The collected blood samples will be used for research projects to study the abnormal plasma cells and compare the results to current tests being done. This will provide an opportunity to better understand how a patient is responding to treatment and to assess the stage of the patient’s disease.

This study will use different tests that are not FDA approved. This test is being studied as a less invasive way to monitor amount of disease in a patient (versus invasive bone marrow biopsy). Current blood tests show the levels of the product of the cancer cell - not the levels of the cells themselves. Sometimes the cancer cells do not make this product and can therefore go undetected in standard tests. This study will show the number of cells. These tests will help identify, and analyze circulating plasma cells (CPCs), which are cells that have escaped into the bloodstream (a characteristic of plasma cell disorders). We will also look at any plasma cell components, such as genes in the DNA and RNA. Part of your samples will be used for Next Generation Sequencing (NGS) to evaluate any changes in your genes. NGS is a useful tool that determines the sequence of your DNA.

This Phase II/III trial will evaluate what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed.

The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.

Volixibat is an experimental treatment, meaning that it has not been approved by the US Food and Drug Administration (FDA) or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels (the amount of certain chemicals that are produced by the liver and are present in the blood) that are believed to lead to the itching in patients with PBC. There are no other medicines approved to treat itching in patients with PBC.

The purpose of this study is to find out if a new test for patients with Wilson’s disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Ceruloplasmin is a protein that helps transport copper from the liver and deliver copper to the rest of your body to maintain your health. In Wilson’s disease, ceruloplasmin levels are low and free copper levels are higher than normal, which can be controlled by taking your Wilson’s disease medications regularly. There is currently no approved test to measure NCC. Your doctor may use a combination of tests including a blood test to measure ceruloplasmin in order to calculate the NCC, but this is not accurate or reliable. Having a more reliable and accurate measurement of NCC may help your doctor, in the future, make better informed decisions about your treatment, including the dose of your medicine.

Contrast Enhanced Ultrasound Study:

• The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
• Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
• Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)

Heart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes.

Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early changes in cardiac function and poor knowledge of CKD-specific mechanisms for both HF and heart failure with preserved ejection fraction (HFpEF).

Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.

The purpose of this study is to learn about the effects of study medication on decreasing damage to the kidneys and find the most effective dose for treating IgAN, and to see how safe the study drug is for patients with IgAN. The study will compare the effects of the study medicine, which is given by injection, with placebo injections to find out if the study drug helps treat IgAN.

This is a phase 2/3 clinical trial looking at the safety and efficacy of the drug Zanubrutinib in Patients with biopsy proven Primary Membranous Nephropathy

The CONQUER Registry will enable researchers to:

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.

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.

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.

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.

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).

We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and also to better understand the studied disease and associated health problems. Anifrolumab is being tested in research studies as a new treatment for systemic sclerosis and the purpose of this study is to find out if anifrolumab is safe to use in systemic sclerosis and can improve the symptoms of the disease.

Participants will be in the research study for approximately 122 weeks (2 years and 3 months). Participants are given an investigational drug and asked to come for approximately 16 study visits.

For 52 weeks, half of the participants will receive 120 mg anifrolumab and half will receive placebo (inactive solution containing no anifrolumab) by injection under the skin (subcutaneous) while continuing to receive their standard therapies. Which study treatment you will be given will be randomly assigned. After 52 weeks, all participants will receive 120 mg anifrolumab (for 52 weeks) to evaluate the long-term safety of the study drug in patients with systemic sclerosis.