Clinical Research

Scleroderma Program clinical researchers and study coordinators are continuously conducting clinical trials and observational studies, along with maintaining numerous registries, in a variety of areas to better understand scleroderma and to find effective treatments for the disease and its complications.

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. Please see below for a list of our current clinical trials.

Observational Studies & Clinical Registries

Observational studies are done to observe a patient’s disease, symptoms, and health over time without introducing an intervention, such as a medication. For clinical registries, data (such as biological, clinical, and self-report) are collected at points over time to evaluate specified outcomes for people with a specific disease or condition. These studies provide us with more knowledge about rheumatologic conditions, like scleroderma, and how we may be able to better diagnosis and treat patients in the future. Please see below for a list of our current observational studies and clinical registries.

Sign Up to Be Contacted About Upcoming Studies

If you are interested in being contacted about upcoming studies, please see below for the Sclero-Rehab Research Recruitment Registry. The purpose of this registry is to inform you about future research opportunities in the UM Scleroderma Program. These study opportunities may be focus groups, behavioral studies, clinical studies, or intervention research. By providing some basic information, we can target our advertisements to specific research opportunities that you might qualify for.
 

Current Clinical Trials

PROMIS Integration Trial

The purpose of this study is to evaluate the effects of Patient-Reported Outcome (PRO) implementation on the processes of care, clinical decision making, patient-provider communication, and health comes.

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We are looking to identify barriers and facilitators to PRO implementation from the perspectives of patients and HCPs to develop and refine approaches to training and supporting HCPs to use PROs effectively as tools for chronic disease management. In doing so, we hope to find ways to improve the use of PROs, health outcomes, patient-provider communication, medical decision making, and patient satisfaction.

Recruitment status

  • Currently recruiting

Who can participate?

  • Adults 18 years or older with rheumatic diseases.

What is involved?

  • We will ask you to complete questionnaires over the course of three months.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: Dinesh Khanna, MD, MSc

 

Horizon

A randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HZN-825 in patients with diffuse cutaneous systemic sclerosis.

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A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Recruitment status

  • Currently recruiting

Who can participate?

  • Adults between the ages 18 and 75 years with a diagnosis of diffuse cutaneous systemic sclerosis whose disease onset is less than 3 years from first non-Raynaud’s manifestations.
  • Eligible participants will be randomized in a 1:1:1 ratio to take the study drug HZN-825 300 mg once daily, HZN-825 300 mg twice daily, or Placebo.

What is involved?

  • The duration of the study is approximately 60 weeks; screening period up to 4 weeks, double-blind treatment period of 52 weeks, and a safety follow-up period of 4 weeks after last dose.
  • All subjects who complete the double-blind treatment period (week 52) will be eligible to enter a 52-week extension trial.
  • Participants will be asked to complete questionnaires and provide blood, urine, and tissue samples at visits.

Who should I contact?

If you have nay questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: David Roofeh, MD

 

Booster Effects with Autoimmune Treatments in Patients with Poor Response to Initial COVID-19 Vaccine

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different COVID-19 booster doses in participants with autoimmune disease requiring immunosuppressive medications.

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COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

All study participants will have negative serologic or sub-optimal responses to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Sanofi-GSK COVID-19 vaccine.

Recruitment status

  • Currently recruiting

Who can participate?

  • Adults 18 and over who have scleroderma, lupus, rheumatoid arthritis or multiple sclerosis who have documented full COVID-19 vaccination, have negative serologic or sub-optimal response to the vaccine regimen, and are currently taking immunosuppressive medications.

What is involved?

  • Study participation will span approximately 13 months.
  • If eligible, participants will be given an additional “booster” vaccination.
  • Participants will be asked to complete questionnaires and provide blood and urine samples at visits.

Who should I contact?

If you have nay questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principal Investigator: Dinesh Khanna, MD, MSc

 

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis

This is a Phase 2, multi-center, randomized, double-bind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of MT-7117 in subjects with diffuse cutaneous systemic sclerosis.

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Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Recruitment status

  • Currently recruiting - enrollment will end at the end of 2022

Who can participate?

  • Adults between the ages 19 and 75 years with a diagnosis of diffuse cutaneous systemic sclerosis whose disease onset is less than 3 years from first non-Raynaud’s manifestations.

What is involved?

  • Eligible participants will be randomized in a 1:1 ratio to take the study drug (MT-7117) or placebo starting at 300mg every day.
  • The duration of the study is approximately 60 weeks; screening period up to 4 weeks, doubleblind treatment period of 52 weeks, and a safety follow-up period of 4 weeks after last dose.
  • Participants will be asked to complete questionnaires and provide blood, urine and tissue samples at visits.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principal Investigator: David Roofeh, MD

 

Brentuximab Vedotin for Systemic Sclerosis (BRAVOS)

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). 

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

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.

Recruitment status

  • 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: ssc-coordinator@umich.edu

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.

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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 status

  • Currently recruiting

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: ssc-coordinator@umich.edu

Principal Investigator: Puja Khanna, MD, MPH

 

Current Observational Studies & Clinical Registries

DoD - ETV2 Dysregulation in Scleroderma Endothelial Cells

The purpose of this project is to take a closer look at the cause for vascular abnormalities in scleroderma and to obtain biological specimens for testing.

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Recruitment status

  • Currently recruiting

Who can participate?

  • Adults between the ages 18 and 75 years with an early diagnosis of diffuse cutaneous systemic sclerosis.

What is involved?

  • We will collect biopsies at your clinic visit.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: Pei-Suen Eliza Tsou, PhD

 

A Molecular Classification Paradigm to Predict Therapeutic Response in Systemic Sclerosis

The purpose of this project is to understand the cause of scleroderma (also known as systemic sclerosis) by collaborating with experts within University of Michigan and Dartmouth College.

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Recruitment status

  • Currently recruiting

Who can participate?

  • Adults between the ages 18 and 75 years with an early diagnosis of diffuse cutaneous systemic sclerosis.

What is involved?

  • We will collect clinical information from your standard of care appointments and procedures.
  • We will collect blood and biopsies at two clinic visits that will take place six months apart.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: Dinesh Khanna, MD, MSc

 

The Role of the Gut Microbiome in Systemic Sclerosis Associated Interstitial Lung Disease

The purpose of this study is to develop a better understanding of the role of the gut microbiome and its association to SSc-ILD to determine if it can be used to predict the development and progression of ILD in patients with connective tissue disease.

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Recruitment status

  • Currently recruiting

Who can participate?

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

What is involved?

  • We will collect clinical information from your standard of care appointments and procedures.
  • We will collect blood at three clinic visits within 12 months.
  • We will ask you to provide a stool sample after each of these three visits using a kit you will take home.
  • We will ask you to complete questionnaires at three clinic visits within 12 months.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: Dinesh Khanna, MD, MSc

 

Study of Inflammatory Arthritis and Interstitial Lung Disease in Early Rheumatoid Arthritis: SAIL-RA

The purpose of this study is to understand why some people with RA develop RA-ILD and others do not.

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Recruitment status

  • Currently recruiting

Who can participate?

  • Adults 18 years or older with an early diagnosis of rheumatoid arthritis.

What is involved?

  • We will conduct research clinic visits and collect blood every six months for two years.
  • We will ask you to complete questionnaires every three months for two years.
  • We will use computed tomography (CT) to image the chest and x-rays to image the hands at the beginning and end of the study.
  • Participants will complete pulmonary function testing and six-minute walk tests annually.

Who should I contact?

If you have any questions or would like more information regarding the study, please contact the study coordinator: ssc-coordinator@umich.edu

Principle Investigator: Jeffrey A. Sparks, MD. MMSc
Site Principle Investigator: Dinesh Khanna, MD, MSc

 

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.

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Through this research, 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.

Recruitment status

  • 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: ssc-coordinator@umich.edu

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).

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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.

Recruitment status

  • Not 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: ssc-coordinator@umich.edu

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.

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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.

Recruitment status

  • Not 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: ssc-coordinator@umich.edu

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.

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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 towards a cure.

Recruitment status

  • 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: ssc-coordinator@umich.edu

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 to monitor lung fibrosis (and the absence of lung fibrosis).

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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 status

  • Currently recruiting

Who can participate?

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

What is involved?

  • 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: ssc-coordinator@umich.edu

Principal Investigator: Dinesh Khanna, MD, MSc

 

Sign Up to Be Contacted About Upcoming Studies

Registry: Sclero-Rehab Research Recruitment

The purpose of this registry is to inform you about future research opportunities in the UM Scleroderma Program. These study opportunities may be focus groups, behavioral studies, clinical studies, or intervention research. By providing some basic information, we can target our advertisements to specific research opportunities that you might qualify for.

Learn More

The Sclero-Rehab Research Registry includes 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.

View the Consent and Registration form.

Recruitment status

  • 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: ssc-coordinator@umich.edu

Principal Investigator: Susan Murphy, ScD OTR/L

 

Past Significant Trials

Past Significant Trials

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