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 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 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.
A Phase II/III, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD)
Recruitment status
- Recruitment expected to begin December 2023
Who can participate?
- Adults ≥ 18 years old
- Diagnosis of diffuse cutaneous systemic sclerosis and systemic sclerosis-related interstitial lung disease (ILD) fibrosis of the lungs with first non-Raynaud’s symptom ≤ 5 years ago.
What is involved?
- The screening period to check for eligibility for participation in the study may take up to 6 weeks.
- Study treatment period with study drug administered weekly over 52 weeks to assess the effects of the study drug on the participants disease and ensure its use is safe. This will be composed of 7 study site visits at Michigan Medicine.
- Safety follow-up visit 8 weeks after the study treatment is completed to monitor any drug related side effects. This will require 1 study site visit at Michigan Medicine and will complete participation in the study.
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: Erica Mulcaire-Jones, MD
A Multicenter, Randomized, Parallel-group, Double-blind, Two-arm, Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared with Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive with Systemic Sclerosis
Recruitment status
- Recruitment expected to begin December 2023
Who can participate?
- Adults ≥ 18 years old with a diagnosis of limited or diffuse cutaneous systemic sclerosis with first non-Raynaud’s symptom ≤ 6 years ago
What is involved?
- The duration of the study is approximately 122 weeks; screening period up to 6 weeks, double-blind treatment period of 52 weeks, open-label treatment period of 52 weeks if patient chooses to continue, and a safety follow-up period of 12 weeks after last dose.
- Participants will be asked to complete questionnaires, provide blood and urine samples at visits, and complete ECG tests, chest CT scans, and pulmonary function tests. Participants can also participate in optional skin biopsy sample collection.
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: Erica Mulcaire-Jones, MD
Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis
Recruitment status
- Recruitment expected to begin February 2024
Who can participate?
- Adults ≥ 18 years old with a diagnosis of systemic sclerosis and interstitial lung disease with first non-Raynaud’s symptom ≤ 5 years ago.
What is involved?
- Study participation will span approximately 60 weeks (4 weeks Screening, 52 weeks Treatment Period, and 4 weeks Follow-up), consisting of 10 visits.
- Participants will be asked to complete questionnaires, provide blood and urine samples at visits, and complete ECG tests, chest CT scans, x-rays, and pulmonary function tests.
Who should I contact?
If you have any questions or would like more information regarding the study, please contact the study coordinator: [email protected](link sends e-mail)
Principal Investigator: Dinesh Khanna, MD, MSc
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).
Recruitment status
- Currently 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
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.
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 any questions or would like more information regarding the study, please contact the study coordinator: [email protected]
Principle Investigator: David Roofeh, MD
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.
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
- Closed to recruitment
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
Item Rating of Existing Patient Reported Outcomes (PROs) in Limited Scleroderma: An Online Survey to Create a PRO Questionnaire for a Combined Response Index for a Scleroderma Trial Assessing Limited Scleroderma (CRISTAL PRO)
Recruitment status:
- Currently recruiting
Who can participate?
- Adults ≥ 18 years old
- A diagnosis of limited systemic sclerosis with first non-Raynaud’s manifestations ≤ 7 years ago.
- Receiving care at Michigan Medicine.
What is involved?
- Participants will be asked a short survey about key demographics.
- The next sets of questions (around 30 questions) will then ask the participant if he/she experienced (currently or in the past) symptoms related to the disease related topics of interest, and they will have the option to answer yes or no.
- If yes, the list of items from the mentioned questionnaire will be provided and the participant will be asked to rate each item based on their importance, and to provide the most important item from their perspective.
- If no, the participant will be asked to skip to the next disease related topic.
- To keep your information confidential, your survey responses will be completely anonymous. No one, including members of our study team, will know which people gave which answers.
- When the survey ends, your participation in this study will be over.
- This survey will allow us to identify for each disease related topics, which items from the literature are the most important items from the participants’ perspectives.
- The end the goal is to include these items in an overall patient survey evaluating Scleroderma as a whole.
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
A Prospective, Multi-national, Cross-sectional Study on a Risk-factor Guided Approach to Interstitial Lung Disease Screening in Patients with Rheumatoid Arthritis at Higher Risk for ILD Using High Resolution Computed Tomography
Recruitment status
- Currently recruiting
Who can participate?
- Adults ≥ 18 years old with a diagnosis of Rheumatoid Arthritis
- Patient must have ≥ 2 of the following risk factors for ILD (i.e., any 2 or more):
- Male
- Current or previous smoker
- Age of ≥ 60 years at RA diagnosis
- Rheumatoid factor high-positive AND/OR anti-CCP high-positive at RA diagnosis or any time after RA diagnosis
- High/severe RA disease activity score at screening visit or within 12 months of screening visit
- Presence or history of these extra-articular manifestations of RA: vasculitis, Felty’s syndrome, secondary Sjogren’s syndrome, cutaneous rheumatoid nodules, serositis and/or scleritis/uveitis
What is involved?
- Study participation will include one research visit and procedures. These may be scheduled for one day or over the span of several days.
- Participants will be asked to complete questionnaires, provide blood samples, and complete a chest CT scan and pulmonary function tests.
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: Erica Mulcaire-Jones, MD
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.
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
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.
Recruitment status
- Closed to recruitment
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 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.
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
The purpose of this study is to understand why some people with RA develop RA-ILD and others do not.
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
The purpose of this study is to develop a database of patients with a recent diagnosis of scleroderma.
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
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.
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
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.
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
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.
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
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).
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
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.
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
