• A Randomized, Open-Label, Phase II/III Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis(SCOT)
  
  
• A Randomized, Double-blind, Placebo-phase Multi-center, Phase 2 Trial of Intravenous Rituximab in the Treatment of Refractory Myositis in Adults and Children (RIM)
  
  
• Pulmonary Hypertension - Assessment and Recognition of Outcomes in Scleroderma (PHAROS)
  
  
• Validation of the Michigan Hand Outcomes Questionnaire as a Disease-Specific Outcome Measure for Scleroderma
  
  
• Development of Scleroderma Gastrointestinal Tract 2.0 (SSC-GIT 2.0) Quality of Life Instrument
  
  
• Endostatin and Other Angiogenic/Angiostatic Mediators in Patients with Systemic Sclerosis
  
  
• Provisional Combined Response Index for Patients with Diffuse Systemic Sclerosis Pulmonary Hypertension (CRISS)
  
  
• Pain, Pain Self-efficacy, and Depression in Scleroderma
  
  

Study Title:

A Randomized, Open-Label, Phase II/III Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCOT)

IRB Number: 2005-0485

Study Team:

Principal Investigator:
Seibold, James, MD; University of Michigan Department of Internal Medicine

Co-Investigators:
Mineishi, Shin, MD; University of Michigan Dept. of Internal Medicine, Hematology-Oncology
Ferrara, James, MD; University of Michigan Dept. of Pediatrics and Internal Medicine
Kaplan, Mariana, MD; University of Michigan Dept. of Internal Medicine, Rheumatology
Lee, Choon-Kee, MD; University of Michigan Dept. of Internal Medicine
Levine, John, MD; University of Michigan Dept. of Pediatrics, Hematology-Oncology
Reddy, Pavan, MD; University of Michigan Dept. of Internal Medicine, Hematology-Oncology
Schiopu, Elena, MD; University of Michigan Dept. of Internal Medicine, Rheumatology
Christina, Tsien, MD; University of Michigan Dept. of Internal Medicine, Radiation Oncology

Purpose:

Severe systemic sclerosis (SSc) is a serious autoimmune disorder in which a person’s own immune cells attack organs in the body. SSc affects the skin, joints, lungs, heart, intestinal tract, and kidneys, and half of the patients with the most severe organ involvement die within 5 years. Treatment for SSc usually includes supportive care or immunosuppressive drugs (drugs to suppress (hold back)) your immune system. As the immune cells are believed to be causing the disease, researchers are looking for new therapies that either slow down or stop this process. The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by re-infusion (transplantation) of the subject’s own autologous (self) peripheral blood stem cells (PBSCs) compared to treatment with monthly (for 12 months) intravenous doses of cyclophosphamide (Cytoxan) therapy for the treatment of severe systemic sclerosis (SSc). These treatments are being given in order to determine if they will slow down or stop SSc from becoming more severe, and if they can reverse the effects of the disease. We are evaluating the effects of the two treatments on serious organ damage and survival related to SSc, while also studying the side effects of the two treatments.

Who can take part in this study?

This study is for patients with severe systemic sclerosis (SSc), also known as scleroderma.

Study Procedures:

For more information about the study and the study procedures: http://www.sclerodermatrial.org

OR

http://clinicaltrials.gov/ct/show/NCT00114530?order=4

Study Contact Person - Scleroderma Program

Study Coordinator:
Bethany Baker, MSA

Mailing Address:

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients

Informed consent required

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Study Title:

A Randomized, Double-blind, Placebo-phase Multi-center, Phase 2 Trial of Intravenous Rituximab in the Treatment of Refractory Myositis in Adults and Children (RIM)

IRB Number: HUM 00003757 (Pediatric) & HUM 00001117 (Adult)

Study Team:

Coordinating Investigator:
Oddis, Chester, MD, Professor of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine
Reed, Ann, MD, Chair, Pediatric Rheumatology, Mayo Foundation and School of Medicine at the Mayo Clinic
Co-Investigators at the University of Michigan:
Seibold, James, MD; Department of Internal Medicine, University of Michigan (Adult)
Schiopu, Elena, MD, Department of Internal Medicine, University of Michigan (Adult)
Ike, Robert, MD, Department of Internal Medicine, University of Michigan (Adult)
Adams, Barbara, MD, Department of Pediatric Rheumatology, University of Michigan (Pediatric)
Haftel, Hilary, MD, Department of Pediatric Rheumatology, University of Michigan (Pediatric)

Purpose:

Who can take part in this study?

Male and female adults and children who have been diagnosed with either DM or PM will be asked to take part in this research study.  This study will be done at approximately 37 centers across North America and Europe.  202 participants will be included in the study (152 adults and 50 children).  Approximately 12 people will participate at the University of Michigan.

Study Procedures:

Baseline data collected will include demographics, disease severity, past history of medications and surgeries, current medications, laboratory data and test results from routine diagnostic testing (EKG & manual muscle testing).  Enrolled patients will be asked to complete questionnaires throughout the study at follow up visits. At baseline, enrolled subjects will be asked to if they would like to participate in two other studies related to this study that involve extra blood for DNA testing and muscle biopsies.  Patients may choose to participate in the main study without participating in the two extra studies.
Subjects will receive a total of 4 doses (infusions) of study drug.  At visit 2 they will be randomized (assigned by chance) to one of two groups.  They will receive both placebo (an inactive solution of saline) and rituximab while participating in this study.

Group A will receive the study drug, rituximab at Visit 2 and Visit 3 followed by a placebo infusion only at Visit 5 and Visit 6.

Group B will receive a placebo infusion only at Visit 2 and Visit 3 followed by an infusion of the study drug rituximab at Visit 5 and Visit 6.

This study is double-blind, which means that the subject and the study staff will not know what study drug they are receiving at each of the four infusion visits.  However, this information is available to the study doctor if needed in an emergency.
Enrolled subjects will have routine blood work done on a regular basis.  Data from these tests will be collected and entered into a database, along with data from the biannual questionnaires and patient assessments.
 
The entire length of the study with 4 infusions and all assessments will continue for 44 weeks.  There are 14 necessary visits to the University of Michigan.

Study Contact Information – University of Pittsburgh:

Study Coordinator - University of Pittsburgh:
Sherrie Pryber, Clinical Study Coordinator

Mailing Address:

University of Pittsburgh
Division of Rheumatology
S 703A BST
3500 Terrace Street
Pittsburgh, PA 15261
pryber@dom.pitt.edu

Telephone:  (412) 647-3241

Study Contact Information – University of Michigan Scleroderma Program:

Study Coordinators – University of Michigan Scleroderma Program:
Bethany Baker and Leah Kramer

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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Study Title:

An Open Label Pilot Study to Assess the Safety and Efficacy of Inhaled Iloprost in Adults with Pulmonary Hypertension Secondary to Interstitial Lung Disease in Systemic Sclerosis

Study Team:

Coordinating Investigator:
Seibold, James R., MD, Department of Internal Medicine, University of Michigan

Co-Investigators:
Schiopu, Elena, MD, Department of Internal Medicine, University of Michigan

McLaughlin, Vallerie, MD; Department of Internal Medicine, University of Michigan

Ojo, Tammy Clark, MD; Department of Internal Medicine, University of Michigan

Chan, Kevin, MD, Department of Internal Medicine, University of Michigan

Purpose:
Lung involvement in scleroderma is present in approximately 80% of the patients with varying contributions of inflammation, scarring and blood vessel injury.  Individuals with blood vessel injury develop pulmonary arterial hypertension (PAH) and have benefited from numerous advances in treatment.  This trial investigates the safety and effectiveness of one of these treatments in a group of patients who have pulmonary hypertension and moderately severe lung scarring.  The treatment, inhaled iloprost, will be administered to 10 well characterized volunteers.  The usefulness of the drug will be assessed by serial exercise testing over 12 weeks.  This is a pilot study; information from which may provide the basis for longer and larger clinical trials.

Who can take part in this study?

Study Procedures:

Study Contact Information:

Study Coordinator:
Ann J. Impens, PhD

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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Study Title:

Pulmonary Hypertension - Assessment and Recognition of Outcomes in Scleroderma (PHAROS)

IRB Number: HUM 00001965

Study Team:

Coordinating Investigator:
Steen, Virginia D., MD, Professor of Medicine, Georgetown University School of Medicine
Co-Investigators at the University of Michigan:
Seibold, James R., MD; Department of Internal Medicine, University of Michigan
Schiopu, Elena, MD, Department of Internal Medicine, University of Michigan

Purpose:

The purpose of this research project is to establish a database of patients with scleroderma who developed or are at increased risk of developing increased pressure in the pulmonary artery called pulmonary arterial hypertension (PAH).  There is minimal prospective data regarding the natural history of PAH in patients with systemic sclerosis and no definite risk factors have been identified to date.  Although there are outcome studies showing PAH as an independent risk for death in cohorts of scleroderma patients, little is known about the initial, pre-PAH stages and how it evolves into severe PAH.  This database will be used to determine the natural history of this complication from early stages to different clinical outcomes and to establish through various testing what the risk factors are for the development of severe pulmonary hypertension.

Who can take part in this study?

Scleroderma patients with a recent diagnosis of pulmonary hypertension or those who are at high risk for developing pulmonary hypertension will be eligible to enroll in this study.  ‘Early PAH’ will include patients that have been diagnosed within the past 6 months that meet certain eligibility requirements.  Patients who are ‘at risk for developing PAH’ must meet certain eligibility requirements from pulmonary function tests and echocardiograms.  These tests are routine for scleroderma patients.  Patients that have been diagnosed and treated for pulmonary hypertension for more than 6 months will not be eligible for this study.

Study Procedures:

Baseline data collected will include demographics, disease severity, past history of medications, current medications, laboratory data and test results from routine diagnostic testing.  Enrolled patients will be asked to complete questionnaires on a biannual basis.  At baseline, enrolled subjects will be asked to give a blood sample that will be frozen and stored for possible future analysis.  Patients may choose to participate in this study without having their blood drawn for possible future analysis.  Enrolled subjects will have routine annual pulmonary function tests, echocardiograms and cardiac catheterization (if warranted) as part of their standard care.  Data from these tests will be collected and entered into a database, along with data from the biannual questionnaires and patient assessments.
This database and patients’ assessments will continue for up to 10 years (contingent on future funding), allowing a better understanding of this complication.

Study Contact Information – Georgetown University:

Study Coordinator - Georgetown University:
Suria Yesmin, Clinical Study Coordinator

Mailing Address:

Georgetown University
PHC Building
Dept. of Rheumatology
3800 Reservoir Road, 6th Floor
Washington, DC 20007

Telephone:  (202) 687-6317

Study Contact Information – University of Michigan Scleroderma Program:

Study Coordinator – University of Michigan Scleroderma Program:
Ann J. Impens, PhD

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

Study Title:

Validation of the Michigan Hand Outcomes Questionnaire as a Disease-Specific Outcome Measure for Scleroderma

IRB Number: HUM 00000390

Study Team:

Principal Investigator:
Chung, Kevin, MD, MS; Department of Plastic Surgery, University of Michigan

Co-Investigators:
Seibold, James, MD; Department of Internal Medicine, University of Michigan

Purpose:

Hand involvement is universal in patients with scleroderma. Studies have identified upper extremity impairment as the dominant factor influencing patient functional status; however, the development of a hand-specific instrument to follow hand function as a primary or secondary end-point may be an important advancement in scleroderma research. This study attempts to validate the Michigan Hand Outcomes Questionnaire (MHQ), an outcomes instrument developed at the University of Michigan, as a disease-specific functional outcomes tool in scleroderma.

Who can take part in this study?

Consenting adults over the age of 18 with a diagnosis of systemic sclerosis (according to classification criteria of the American College of Rheumatology) and who have clear evidence for a reliable classification as diffuse or limited cutaneous scleroderma can participate in this study. Ineligibility for the study is based on the following conditions: active hand infection, ischemic digit (a decrease in the blood supply caused by constriction or obstruction of the blood vessels) or established demarcated proximal digital gangrene (distinguishable gangrene of the fingers), anticipated need for surgery in the next 6 months, and an unstable systemic disease (for instance, a new onset of scleroderma renal crisis).

Study Procedures:

Study participants will be given the Michigan Hand Outcomes Questionnaire (MHQ), the SF-36 and the HAQ-DI to complete while waiting to be seen in the clinic for routine clinical care. These surveys can be completed in approximately 30 minutes. Participants may be asked to return for a second visit within the next 14 days. The same routine clinical care and MHQ will be re-administered in the second visit. If you are unable to return to the clinic for a second visit, the MHQ may be mailed to you for you to complete at home and mail back to us.

Study Contact Information:

Study Coordinator:
Sandra Kotsis, MPH

Mailing Address:

2130 Taubman Center
1500 East Medical Center Drive
Ann Arbor, MI 48109-0340

Telephone: 734-615-6550

Study Contact Information - Scleroderma Program:

Study Coordinator:
Ann J. Impens, PhD

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients

Informed consent required.

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Study Title:

Searching for Clues to the Pathobiology of Pulmonary Hypertension

IRB Number: 2005-0082

Study Team:

Principal Investigator:
Rubenfire, Melvyn, MD; Professor of Internal Medicine, University of Michigan

Co-Investigators at the University of Michigan:
Kaplan, Mariana, MD; Assistant Professor of Internal Medicine
McLaughlin, Vallerie, MD; Associate Professor of Internal Medicine
Martinez, Fernando, MD; Professor of Internal Medicine
Seibold, James, MD; Professor of Internal Medicine
Pinsky, David, MD; Professor of Internal Medicine
Peters-Golden, Marc MD; Professor of Internal Medicine
Standiford, Theodore, MD; Professor of Internal Medicine
Ruwende, Cyril, MD, PhD; Assistant Professor of Internal Medicine
Schiopu, Elena, MD; Lecturer, Internal Medicine

Co-Investigators at the Institute of Respiratory Disease; University of Milan
Blasi, Francesco, MD
Bossone, E duardo, MD, PhD
Bodini, Bruno, MD; (Visiting Research Fellow, University of Michigan)
Specialty School of Occupational Medicine; University of Milan
Lippo, Giusseppina, MD; (Visiting Research Fellow, University of Michigan)

Purpose:

The purpose of this study is to obtain a better understanding of the triggers and modulators of pulmonary arterial hypertension. This may lead to improved and targeted therapies. Pulmonary hypertension (PH) or elevation of the pulmonary artery pressure results from the body’s response to various stimuli including disease states, which, when chronic, can lead to pathologic changes in the blood vessels of the lung.

Who can take part in this study?

Patients with scleroderma, pulmonary fibrosis, and other causes of pulmonary arterial hypertension are eligible. We also will need healthy normals, and patients with coronary artery disease. The study will include approximately 170 subjects.

Study Procedures:

• Medical Records Review: the research team will review your medical records at the University of Michigan and information made available by other physicians. This information will be entered into the research record.
• Blood Draw: up to 4 tablespoons of blood will be drawn. An additional 6ml (1 teaspoon) blood sample will be drawn if you agree to participate in the genetic component of this study. This blood will be used to test for DNA analysis relating to pulmonary hypertension and related diseases.
• Cardiac Ultrasound: If you have not had a cardiac ultrasound at the University for clinical purposes in the past 3 months, one will be performed.
• Follow-up: Your medical progress may be followed by the research team for up to 5 years. You will be contacted yearly by phone or by mail to obtain information regarding your health status. Your physician may be requested to provide information regarding your progress. Additionally you may be invited to have follow-up blood tests and an ultrasound of the heart at intervals of 2 and 4 years.

Study Contact Information:

Study Coordinator:
Karen Schultz, BBA

Mailing Address:

Preventive Cardiology
24 Frank Lloyd Wright Drive
Ann Arbor, MI 48106-0363

Telephone: 734-998-7411

Study Contact Information - Scleroderma Program:

Study Coordinator:
Leah Kramer, BS

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients

Informed consent required

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Study Title:

Scleroderma and Myositis Cohort

IRB Number: 2002-0748

Study Team:

Principal Investigator:
Seibold, James, MD; Department of Internal Medicine, University of Michigan

Co-Investigators:
Schiopu, Elena, MD; Department of Internal Medicine, University of Michigan
Somers, Emily, PhD; Department of Internal Medicine, University of Michigan
Kocheril, Sosa, MD; Department of Internal Medicine, University of Michigan

Purpose:

This is a descriptive registry that has been active at the University of Michigan for many years. Key information about disease characteristics, severity and outcomes are catalogued. A main objective is to develop solid information about the natural history of disease.

Study Contact Information - Scleroderma Program:

Study Coordinator:
Ann J. Impens, PhD

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients

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Study Title:

Development of Scleroderma Gastrointestinal Tract 2.0 (SSC-GIT 2.0) Quality of Life Instrument

IRB Number:  HUM00015237

Study Team:

Coordinating Investigator(s):
Furst, Daniel, MD, Khanna, Dinesh, MD, Clements, Philip, MD, from the Rheumatology Division at the University of California, Los Angeles (UCLA) initiated this study and UCLA is the coordinating center.  The University of Michigan is subcontracted by UCLA and is one of the three co-investigating sites. 
Co-Investigators at the University of Michigan:
Seibold, James, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Schiopu, Elena, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Phillips, Kristine, MD, PhD; Department of Internal Medicine, Division of Rheumatology, University of Michigan

Purpose:

Scleroderma is an autoimmune disease of the connective tissue.  Autoimmune diseases are illnesses that occur when the body's tissues are attacked by its own immune system. Scleroderma is characterized by the formation of scar tissue (fibrosis) in the skin and organs of the body. This leads to thickening of involved areas.
Gastrointestinal tract (GIT) is the most common organ system involved in scleroderma.  Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus.  GIT involvement in scleroderma can be severely debilitating and even life threatening.  Some problems associated with GIT may include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing, constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract), diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines), and the inability to control your bowel movements.

Researchers at UCLA have developed a new quality of life instrument to assess the severity of your GIT involvement due to scleroderma and its affect on physical and mental well-being. The purpose of the study is to validate this instrument for scleroderma care and future clinical trials focusing on improving GIT symptoms.

Who can take part in this study?

This study is for patients with scleroderma who are over the age of 18 and had bothersome GIT signs and symptoms in the last 3 months.

Study Procedures:

If you agree to participate in this study, you will complete several questionnaires during your routine visits at the clinic.  This study requires 2 times at which you will complete the questionnaires.  They will be separated by 3 to 6 months.  At each visit the following will be done:

• Complete SF-36 Questionnaire.  This questionnaire will ask you questions about how you feel and how well you are able to do your usual activities,
• Complete SSC-GIT 1.0 Questionnaire.  This questionnaire will ask you questions about your GIT disease and how it is affecting your life,
• Complete the Scleroderma – Health Assessment Questionnaire (S-HAQ) Questionnaire.  This questionnaire will ask you questions about any vascular (blood vessels) problems you may have such as Raynaud’s phenomenon and digital ulcers, any GIT symptoms, any lung symptoms, and your overall severity of your disease,
• Complete the Center for Epidemiological Study of Depression Scale (CESD) Questionnaire.  This questionnaire will ask you questions about your mood and it’s affects on your daily activities,
• Complete Categorical Self Rating of Severity and Activity of Overall, Upper, and Lower GI Involvement questions.  For example, “During the past 1 week, how severe were your overall gastrointestinal (gut) symptoms due to your scleroderma?”

We will also collect information about you by reviewing your medical chart at each visit.  During these visits tests may be ordered, however, these tests are part of your standard of care treatment and not part of this study.  You would have these tests even if you were not in this study.  The information collected may be from the following tests and procedures:

• Demographic data.  This includes year of birth, gender, ethnic origin, annual income, year your disease was diagnosed,
• GIT symptoms and severity,
• Medications you are taking for your GIT problem.
• Skin score (skin thickness at 17 different areas)
•  

The questionnaires that you completed will be stored at UCLA for 10 years after the completion of all data analysis or 20 years, whichever is longer and then your data will be destroyed.
Once you have completed the 2 visits, your participation in this study is completed.  You will continue to return to the clinic for your routine visits and have tests and procedures done as part of your standard of care treatment.

Study Contact Information – University of Michigan Scleroderma Program:

Study Coordinator – University of Michigan Scleroderma Program:
Ann J. Impens, Ph.D.

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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Study Title:

IRB Number:  HUM 11196

Study Team:

Coordinating Investigator(s):
Jaffe, Michele L, MD, MPH; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Seibold, James R, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Koch, Alisa E, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan

Purpose:

Who can take part in this study?

Persons who are 18 years of age and older, can read and write English, have systemic sclerosis (scleroderma) with skin involvement above the elbow and/or knee or have no chronic health conditions which require daily use of medications can participate in the study.  Persons are not eligible for the study if their systemic sclerosis is a result of being exposed to chemicals or drugs that can cause a scleroderma-like illness, they have an overlap of systemic sclerosis with another autoimmune disease (for example, lupus or rheumatoid arthritis) or have been treated with a medication called cyclophosphamide in the past 8 weeks.  Also, subjects are not eligible if they report a history of active infection (including hepatitis C, hepatitis B, or HIV) or are prone to bleeding because they are treated with medications that thin the blood or have a low platelet count.  All participants must provide written informed consent and be willing to comply with laboratory tests.

Study Procedures:

On the first day, all subjects and healthy controls will sign the informed consent, and have two tubes of blood drawn from their arm to confirm that they do not have an excessive tendency to bleed.  Later that day, or on any of the next 30 days following signing of the informed consent, all subjects and healthy controls will have their blood drawn and skin biopsied and subjects with scleroderma will have a brief medical history and an examination of their joints and skin will be performed.  All subjects with scleroderema and healthy controls will have 10 cc (two tubes) of blood drawn from their arm.  For subjects with scleroderma, the skin will be anaesthetized (numbed with a shot of numbing medication under the skin) in the lower and upper arm and two samples of their skin will be biopsied.  For healthy subjects, the skin will be anaesthetized (numbed with a shot of numbing medication under the skin) in the lower arm and one sample of their skin will be biopsied.  In patients with scleroderma and in healthy controls, the skin will be anaesthetized with a small amount of lidocaine placed under the skin with a needle.

Study Contact Information – University of Michigan Scleroderma Program:

Study Coordinator – University of Michigan Scleroderma Program:
Bethany Baker or Leah Kramer

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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Study Title:

Provisional Combined Response Index for Patients with Diffuse Systemic Sclerosis Pulmonary Hypertension (CRISS)

IRB Number: HUM 00015154

Study Team:

Coordinating Investigators:
Furst, Daniel E, MD, Khanna, Dinesh, MD, and Clements, Philip, MD from the Rheumatology Division at the University of California, Los Angeles (UCLA) initiated this study and UCLA is the coordinating center.

Co-Investigators at the University of Michigan:
Seibold, James, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Schiopu, Elena, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Phillips, Kristine, MD, PhD; Department of Internal Medicine, Division of Rheumatology, University of Michigan

Purpose:

Scleroderma is an autoimmune disease of the connective tissue.  Autoimmune diseases are illnesses that occur when the body's tissues are attacked by its own immune system. Scleroderma is characterized by the formation of scar tissue (fibrosis) in the skin and organs of the body. This leads to thickening of involved areas. Diffuse Scleroderma is diagnosed whenever there is tight skin above the elbows or knees (the face doesn’t count in this definition).  The cause of scleroderma is not known, however, inheritance (or genes) seems to play a role in this disease as do some environmental factors.  In scleroderma, internal organs including the lungs, heart, digestive tract, kidney, muscles, and nerves can be involved.
There is no approved treatment by the Food and Drug Administration (FDA) for scleroderma.  The purpose of the study is to develop a response criteria (measure) for clinical trials in diffuse scleroderma that can assist in developing new therapies and hopefully, can lead to effective treatments for scleroderma.

Who can take part in this study?

This study is for patients with early diffuse scleroderma (less than 5 years of disease) who are over the age of 18.

Study Procedures:

Participation in this study will take place during 3 routine clinical visits: baseline (start of study), and again at about months 6 and 12.  Data collected includes demographics, disease severity, past history of medications, current medications, laboratory data and test results from routine diagnostic testing.  A skin examination (part of routine clinic visit) will be conducted to determine how hard and thick the skin is by using a device called a durometer, which applies light pressure to parts of your arms and legs for a few seconds at a time.
Patients will complete several questionnaires.  One questionnaire is called the Health Assessment Questionnaire Disability Index (HAQ DI) and asks questions about the disease and how it affects activities of daily living.  Another questionnaire is called SF-36 and it asks questions about quality of life.  Other questionnaires asks about shortness of breath (BORG Dyspnea Scale and St. George’s Respiratory Questionnaire).  Questions are also asked regarding how Raynauds’s (a condition that causes some areas of your body — such as your fingers, toes, tip of your nose and your ears — to feel numb and cool in response to cold temperatures or stress) affects your function and about how your digestive system affects you.  These questionnaires should take about 30 to 40 minutes at each visit to complete. 

Study Contact Information – University of California Los Angeles (UCLA)

Principal Investigator:
Dinesh Khanna, MD

Mailing Address:

University of California Los Angeles
Dept. of Rheumatology
1000 Veteran Ave, #32-59 Rehab
Los Angeles, CA 90024

Telephone:  (310) 825-2448

Study Contact Information – University of Michigan Scleroderma Program:

Study Coordinator – University of Michigan Scleroderma Program:
Ann J. Impens, PhD

Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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Study Title:

Pain, Pain Self-efficacy, and Depression in Scleroderma

IRB Number: HUM 00014737

Study Team:

Principal Investigator:
Seibold, James, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Co-Investigators:
Jaffe, Michele, MD, MPH; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Phillips, Kristine, MD,PhD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Schiopu, Elena, MD; Department of Internal Medicine, Division of Rheumatology, University of Michigan
Ann J. Impens, PhD; Department of Internal Medicine, Division of Rheumatology, University of Michigan

Purpose:

The purpose of this research project is to obtain a better understanding of the level of pain and depression experienced by scleroderma patients and its impact on quality of life.  Pain reported by scleroderma patients has been linked to physical functioning but surprisingly little research has been done on the importance and impact of pain in this patient population.

Who can take part in this study?

English-speaking patients of the University of Michigan Scleroderma Clinic aged 18 and older are eligible to participate in this study.

Study Procedures:

Study participants are asked to complete several questionnaires.  These questionnaires will ask questions about the level of pain they experience, how they deal with this pain, about depression, and quality of life.  Participants will also be asked some questions about how their scleroderma affects their day-to-day activities and about the severity of their disease. 
As part of this study, information about their disease will also be taken from medical records.  This information includes: demographic information (e.g., age, gender, race), length of disease, type of disease, medications, digital ulcers, and other organ involvement. in this study.  .

Study Contact Information

Study Coordinator:
Ann J. Impens, PhD
Mailing Address:

University of Michigan Scleroderma Program
Domino's Farms
24 Frank Lloyd Wright Drive
P.O. Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone: (866) 628-9200

Study Status:

Currently Enrolling Patients
Informed consent required

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