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.
Study Coordinators
Rosemary Gedert completed her Bachelor’s Degree in Biomolecular Science in 2021 at the University of Michigan, then completed her Master’s Degree in Biochemistry at the University of Michigan Medical School in 2022. Rosemary began working at Michigan Medicine shortly after in May 2022. She is the main study coordinator for many of the observational studies focused on scleroderma and rheumatoid arthritis at Michigan Medicine.
Ryan Lee graduated from the University of Michigan in 2019 with a Bachelor of Science in Chemical Engineering. Ryan later completed a career changing pre-med postbacc at Case Western Reserve University in 2021. He joined Michigan Medicine at the beginning of 2022 and works closely with Dr. Dinesh Khanna and Dr. David Roofeh on their scleroderma research. Ryan is the main study coordinator for several ongoing clinical trials within the Scleroderma Program, ranging from a NIH-funded COVID-19 booster vaccine study to industry-funded drug studies aiming to treat scleroderma.
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: [email protected]
Principle Investigator: Dinesh Khanna, MD, MSc
Prometheus
A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of PRA023 in subjects with systemic sclerosis associated with interstitial lung disease (SSc-ILD).
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Recruitment status
- Not yet recruiting
Who can participate?
- Adults greater than or equal to the age of 18 with a diagnosis of diffuse cutaneous systemic sclerosis (whose disease onset is less than 5 years from first non-Raynaud’s manifestations) and SSc-related ILD of fibrotic disease.
What is involved?
- Eligible participants will be randomized in a 1:1 ratio to receive an IV Infusion of the study drug PRA023 (starting at 1000 mg IV on Week 0/Day 1, followed by 500 mg on Week 2, then every 4 weeks through Week 46) or Placebo (0.9% normal saline IV on Week 0/Day 1, Week 2, and every 4 weeks through Week 46).
- The duration of the study is approximately 54 weeks; screening period up to 4 weeks, double-blind treatment period of 46 weeks, and a safety follow-up period of 4 weeks after last dose.
- All subjects who complete the Double-Blind treatment period (week 50) irrespective of treatment assignment, will be eligible to enter a 50-Week OLE starting at the Week 50 visit of the trial.
- 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: [email protected]
Principle Investigator: David Roofeh, MD
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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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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Principal Investigator: Susan Murphy, ScD OTR/L
Past Significant Trials
Past Significant Trials
- Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis
- BRAVOS: Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase I/II Multicenter, Randomized, Double-Blinded Safety Study
- SLS III: Scleroderma Lung Study III: Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease
- 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)”
- 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
- Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, and Explore Efficacy of GSK2330811
- Evaluation of Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
- A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis
- A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET)
- Pilot study to assess the efficacy and safety of riociguat vs. placebo in scleroderma–associated digital ulcers (RESCUE)
- DUAL-1: Digital Ulcers with macitentan in systemic sclerosis. Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis
- Patient Reported Outcomes Measurement Information System (PROMIS) Network Study: Development and Initial Validation of PROMIS GI Symptoms Scale
- A Phase 2a Randomized Double-Blinded, Placebo and Active Controlled Two Cohort Two Doses Cross-Over Multi-Center Clinical Study to Assess Efficacy of a Once Daily Administration of a Phosphodiesterase 5 Inhibitor (PF‑00489791) for the Treatment of Vasospasm in Primary and Secondary Raynaud’s Phenomenon, A7331010 (VAMPS)
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma
- Digital Ischemic Lesions in Scleroderma Treated with Oral Treprostinil Diethanolamine: An Open-Label Multicenter Extension Study (TDE-DU-202/DISTOL-EXT)
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