Research Opportunities

Researchers in the Scleroderma Program are continuously conducting clinical and observational studies in a variety of areas.

Clinical Trials

Clinical trials are research studies that evaluate an intervention, whether it be a drug, device, or procedure. For our scleroderma-related clinical trials, we primarily study drugs to see if they may be beneficial in relieving symptoms associated with scleroderma. Many of the drugs we study are approved by the FDA to treat other conditions not related to scleroderma, but have not yet been evaluated for use in treating scleroderma-associated symptoms.

Observational Studies

Observational studies are studies that observe a patient’s disease, symptoms, and health over time without introducing a physiological intervention, such as a medication. These studies provide us with more knowledge about scleroderma and how we may be able to better diagnosis and treat patients in the future. Many of our observational studies are registries, which create databases of patients with a specific disease.

Current Clinical Trials

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

IgPro10 (IVIG): A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis

This study is being carried out to see if IgPro10 is effective and tolerated when administered to adults with SSc who have skin thickness involvement throughout their body. This form of SSc is called diffuse cutaneous systemic sclerosis (dcSSc). IgPro10 is a medication which is made from a type of protein in human blood called immunoglobulin G (IgG). Immunoglobulins are responsible for counteracting bacteria, viruses, toxins and allergens. IgPro10 is approved in 86 countries, including the United States and Europe under the brand name Privigen® for other diseases, but has not yet been approved for systemic sclerosis. This study will evaluate the benefit and risks of IgPro10 in the treatment of dcSSc, administered intravenously (as an infusion with a needle through your skin into the vein).

  • Currently Recruiting

Who can participate?

  •  Adults 18 years or older who have been diagnosed with diffuse cutaneous systemic sclerosis (dcSSc).

What is involved?

  • Depending on which group you are assigned, you will either receive infusions of IgPro10 or placebo every 4 weeks. This will be administered daily for 2-5 consecutive days throughout a 48-week period (Masked Treatment Period).
  • If you respond well to the drug or placebo and continue to meet study safety criteria, you will receive IgPro10 intravenously for 24 weeks, following the Masked Treatment Period.
  • Blood and urine samples will be taken at some visits.
  • Questionnaires are encouraged at some visits.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Vivek Nagaraja, MD

Brentuximab Vedotin for Systemic Sclerosis (BRAVOS) 

BRAVOS: Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase I/II Multicenter, Randomized, Double-Blinded Safety Study

The purpose of this study is to evaluate the safety and tolerability of brentuximab vedotin (BV) versus placebo (a substance with no active ingredients and therefore may have no treatment benefit) in patients with dcSSc (diffuse systemic sclerosis). BV is approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancers of the lymph system. In cancer patients being treated with BV who also have autoimmune disease, there have been a few reports of improvement in their autoimmune disease symptoms. This study will evaluate three different doses of brentuximab to determine if this drug decreases symptoms associated with dcSSc and to examine the effect it has on the immune system by looking at blood and skin samples.

  • Currently Recruiting

Who can participate?

  • Adults between 18 and 70 years of age who have had diffuse scleroderma for less than 5 years and have an mRSS between 15 and 45 at the screening visit.

What is involved?

  • Depending on which group you are assigned, you will either receive brentuximab or placebo intravenously every 3 weeks for 21 weeks (a total of 8 doses).
  • Three doses of BV are being studied over time: 0.6 mg/kg, 1.2 mg/kg, and 1.8 mg/kg (1.8 mg/kg is the approved dose for cancer treatment).
  • Monitoring visits will continue for up to one year after the last dose of brentuximab or placebo is given.
  • Blood tests and skin biopsies will be taken at some visits.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

Scleroderma Lung Study III- Combining Pirfenidone with Mycophenolate (SLSIII)

SLS III: Scleroderma Lung Study III: Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease

This research will compare the safety and effectiveness of mycophenolate taken as the only study drug versus mycophenolate taken with pirfenidone for scleroderma-related lung disease. This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma-related lung disease. 

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older who have been diagnosed with scleroderma that has been active for less than 7 years and have lung involvement.

What is involved?

  • You will be randomly assigned to receive mycophenolate capsules with a placebo (a sugar pill with no active medication) or to receive mycophenolate capsules with pirenidone capsules.
  • Mycophenolate will be prescribed up to a target dose of 1.5 g twice a day, as tolerated. Pirenidone will be prescribed up to a target dose of 801 mg 3 times a day, as tolerated.
  • Blood and urine samples will be taken for testing at most visits.
  • You will be asked to complete questionnaires at some visits.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Vivek Nagaraja, MD

Intravenous Iloprost in Subjects with Symptomatic Raynaud’s Phenomenon Secondary to Systemic Sclerosis (Phase 3)

EICOS Sciences, Inc.:A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects with Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)”

This research study is being done to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud’s Phenomenon (RP) attacks in people with SSc. The purpose of this research study is to access if the study drug, iloprost, has an effect on how often symptomatic RP attacks occur, and the safety and tolerability of using iloprost to treat symptomatic RP attacks.

  • Recruitment Starting Fall 2020

Who can participate?

  • Adults 18 years or older who have been diagnosed with Systemic Sclerosis (SSc) and are experiencing symptomatic digital ischemic episodes, known as Raynaud’s Phenomenon (RP) attacks.

What is involved?

  • Participants will be randomly assigned to receive iloprost or a placebo given intravenously (IV) through the arm.
  • Participants must visit the study center for 5 consecutive days to receive the infusions. Infusions will take 6 hours each day.
  • Blood samples and ECG (Electrocardiogram) will be taken at some visits.
  • You will be asked to complete questionnaires.
  • Compensation will be given for completing infusions and questionnaires, and you may be reimbursed for the cost of meals, parking, and traveling to and from the study center.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Vivek Nagaraja, MD

Current Observational Studies

CONQUER: COllaborative, National, QUality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients

The purpose of this study is to develop a database of patients with a recent diagnosis of scleroderma. We are hoping to find information about scleroderma that will help us treat patients in the future, develop new treatments, and work towards a cure.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older with an early diagnosis of systemic sclerosis.

What is involved?

  • We will ask you to fill out questionnaires that take about 20-30 minutes.
  • We would also ask for blood samples at each of your visits.
  • We will collect clinical information from your standard of care appointments and procedures.
  • With your permission, we will store some of your specimens so that investigators can utilize them in future research.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

CTD-ILD: Response Index

The purpose of this study is to develop a collection of data from patients with connective tissue disease (CTD) associated interstitial lung disease (ILD). We will collect blood and skin biopsy (only from scleroderma patients) to assess markers that may help with early detection of progressive ILD. In addition, the data that is collected from the standard of care tests and surveys in this study will be used as a data driven part of the development of reliable patient responses that can be used to develop new treatment for patients with CTD-ILD.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older 18 who have been diagnosed with a connective tissue disease (CTD) with interstitial lung disease (ILD).

What is involved?

  • We will ask you to complete questionnaires at your regularly scheduled standard of care appointments.
  • We will collect blood samples at some visits.
  • We will collect clinical information from your standard of care appointments and procedures.
  • We may ask for skin biopsies, although these are optional and only applicable to scleroderma patients.
  • We will pay you $10 for completion of questionnaires, $10 for blood draw in addition to $10 for skin biopsies at each visit. No other compensation will be provided.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

PRESS: Prospective Registry of Early Systemic Sclerosis, Phenotypic, Serologic, and Biomarker/Genetic Characteristics of Early Diffuse Cutaneous Systemic Sclerosis

The purpose of this project is to take a closer look at scleroderma patients’ clinical, radiological, and laboratory information associated with routine medical care, and to obtain biological specimens for testing. In addition, we hope to explore the impact of scleroderma on patients’ daily lives and medical care. By looking at all of these areas, we hope to find out information about scleroderma that will help us to treat future patients, develop new treatments and work toward a cure. This registry also will help us to identify patients who may be interested in participating in future scleroderma studies.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older who have been diagnosed with systemic sclerosis and have had symptoms for less than 2 years.

What is involved?

  • We will ask you to complete questionnaires at your regularly scheduled appointments. These can be completed online or on paper.
  • We will collect clinical information from your standard of care appointments and procedures.
  • We will collect blood samples at some visits, although this is optional.
  • We may ask for skin biopsies, although these are optional.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

Pathogenesis of Scleroderma

The purpose of this project is to take a closer look at scleroderma patients’ clinical, radiological, and laboratory information associated with routine medical care, and to obtain biological specimens for testing. To do so, participants with different types of scleroderma and scleroderma-like disease will be categorized under different sub-studies. We hope to find out information about scleroderma that will help us to treat future patients, develop new treatments and work toward a cure.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older with a diagnosis of scleroderma or scleroderma-like disease.
  • Healthy volunteers without a diagnosis of scleroderma or scleroderma-like disease.

What is involved?

  • We will collect clinical information from your standard of care appointments and procedures.
  • We may collect blood samples at some visits. Sample collection is dependent on your specific diagnosis and which sub-study you may fall under.
  • We may ask for skin biopsies, although these are optional.
  • We will ask if we can store some of your specimens so that future testing may be done.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

CRISTAL Index Focus Group: Symptom Experience of Individuals with Limited Systemic Sclerosis

We’re doing a study to learn more about the symptoms of systemic sclerosis, commonly called scleroderma. We want to better understand your experience of symptoms of scleroderma and the specific impact of these symptoms on your daily life. To get information, we’d like 45 people to participate in focus groups, with 6 to 8 patients per group. A focus group is an informal group discussion, lasting up to two hours. We will be audio-recording the discussion.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older with a diagnosis of Limited Systemic Sclerosis (lcSSc).

What is involved?

  • You will be asked to contribute to a discussion about your experience of scleroderma-related symptoms and how they affect your daily routines and activities.
  • You will also be asked to fill out a brief survey at the end of the discussion.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

Registry: Sclero-Rehab Research Recruitment

On behalf of the University of Michigan’s Department of Physical Medicine and Rehabilitation, we are asking permission from you to store some of your personal and contact information in the Sclero-Rehab Research Registry, a registry of volunteers who have expressed an interest in taking part in future research for people with scleroderma. We will build and maintain this registry in order for investigators to be able to contact you with information about future research.

  • Currently Recruiting

Who can participate?

  • Adults 18 years or older with a diagnosis of scleroderma.

What is involved?

  • We will collect contact and personal information to be stored in our registry.
  • We may give your personal and contact information to other researchers whose research is approved by an Institutional Review Board (IRB).
  • We will have access to your medical record to verify your diagnosis and characteristics of your condition and maintain up-to-date contact information.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Susan Murphy, ScD OTR/L

IMSS: Intestinal Microbiome in Systemic Sclerosis

We are studying the gut microbiome, or community of bacteria in the gut of people with scleroderma. Some people with scleroderma experience severe GI symptoms while others experience very few of these symptoms. We are hoping that studying the specific bacteria found in the gut will give us clues that may help us develop better treatments for these symptoms in the future.

  • Recruitment Starting Fall 2020

Who can participate?

  • Adults 18 years or older with untreated systemic sclerosis.

What is involved?

  • We are looking for volunteers who are willing donate a stool sample. This is a one-time collection that can be done at home.
  • We will ask you to complete a 10-minute questionnaire that will give us an idea of the GI symptoms you experience.
  • We will collect clinical information from your standard of care appointments and procedures.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

SScreen-ILD: Screening High Resolution Computed Tomography Scan of the Chest to Detect Interstitial Lung Disease in Systemic Sclerosis

The purpose of this study is to develop a database of patients with a recent diagnosis of scleroderma. We are monitoring lung fibrosis (and the absence of lung fibrosis) in these patients to determine how it develops, progresses or stabilizes in order to better understand scleroderma-related interstitial lung disease, and to promote guidelines for screening patients.

  • Recruitment Starting Fall 2020

Who can participate?

  • Adults 18 years or older with an early diagnosis of systemic sclerosis.

What is involved?

  • We are collecting blood and urine samples.
  • We would have you answer questionnaires at 2 different study visits that will take place 1 year apart. The questionnaires generally take around 20-25 minutes and you can take them home and mail them back to us if you’d prefer.
  • We will collect clinical information from your standard of care appointments and procedures.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Dinesh Khanna, MD, MSc

ArthritisPower Trial: Impact of a Mobile Health Application on Rheumatoid Arthritis

The goal of this study is to improve disease outcomes and health related quality of life for patients with rheumatoid arthritis (RA) by improving shared decision-making about treatment options. We believe that having patients collect data on their symptoms and health status between clinic appointments and providing this information to them and their rheumatology health care providers will improve the quality of the patient-provider interaction. However, this is not currently the standard of care. We anticipate this will improve shared decision-making and lead to better disease control and enhance health-related quality of life.

  • Recruitment Starting Fall 2020

Who can participate?

  • Adults 18 years or older with a diagnosis of rheumatoid arthritis (RA) who’s provider is participating in the study.

What is involved?

  • Depending on your health care provider, you may be placed into one of two study groups. One group will use the Arthritis PowerTM  app for the first year of the study and the other will not.
  • After the first year of the study, all participants, no matter their study group, will be encouraged to use the Arthritis PowerTM  app for up to two years.
  • Participants will be asked to complete surveys at some of their regularly scheduled standard of care appointments.
  • We will collect clinical information from your standard of care appointments and procedures.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator below.

Principal Investigator: Vivek Nagaraja, MD

Past Significant Trials

Past Significant Trials

 

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