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Current Clinical Trials


Study Title:

A clinical trial of N-Acetyl Cysteine (NAC) for Connective Tissue Disease-associated with Interstitial Lung Disease (CTD-ILD)

IRB Number: HUM00049434

Study Team:

Principal Investigator:
Trivedi, Mona, MD, Department of Internal Medicine, Division of Rheumatology, Scleroderma Program, University of Michigan

Coordinating Investigators:
Phillips, Kristine, MD, PhD,  Department of Internal Medicine, Division of Rheumatology, University of Michigan, Scleroderma Program

Khanna, Dinesh, MD, MS, Department of Internal Medicine, Division of Rheumatology, University of Michigan, Scleroderma Program

Study Purpose:

The primary purpose of this study is to evaluate the safety and effectiveness of N-acetyl cysteine (NAC), an antioxidant, for connective tissue disease associated with interstitial lung disease (CTD-ILD).  It is currently used for rescue treatment in acetaminophen overdose and prevention of kidney damage caused by contrast material used in radiology imaging studies.  This study is an off-label use of NAC.  NAC is considered a nutritional supplement, so it is not FDA-regulated or approved as a drug; as such, the efficacy and safety of the product are unknown.  This means the drug is not approved for use with patients with your disease and is considered experimental for your disease condition. 

Who can take part in this study?

Males and females ages 18 and above, who are English speaking and diagnosed with CTD-ILD.  Connective tissue diseases may include rheumatoid arthritis, myositis, scleroderma, or Sjogren’s syndrome.  Participants should be able to return to clinic for follow up every three months.  Women of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least 2 years are not considered to be of child-bearing potential.  You will not be allowed to smoke tobacco or take nitroglycerin while you are participating in this study.

Study Procedures

After you sign this informed consent, if you meet all the study entry criteria you will return to the study center for five more visits.

At your baseline and follow up visits you will have a physical exam by a member of the study team, answer some questions about your health and medical history, have blood drawn for your baseline blood count, liver, and kidney function, and have a pregnancy test, if applicable.  You will be asked to complete six questionnaires which assess your disease symptoms and overall health status.  You will also have blood drawn at these visits for analyzing specific proteins that may be affected by NAC.  No genetic testing will be done on your blood samples.  These blood samples drawn at your study visit will be stored with your medical registration number.  You will also have pulmonary function testing done at each visit.   

You will receive NAC for the entire duration of the study.  The medication will be given to you at your baseline visit and again at each follow up visit.  The medication is in the form of a pill and will be taken three times a day every day.

You will need to bring your study drug and containers to each visit so the study team can check your supply.

Study Coordinator:
Julie Konkle, BSN, RN, CCRP

Mailing Address:
University of Michigan Scleroderma Program
24 Frank Lloyd Wright Drive
PO Box 481, Lobby M, Suite 2500
Ann Arbor, MI 48106

Telephone:
(866) 628-9200

Study Status:
Currently Enrolling Patients
Informed consent required


Study Title:

Scleroderma Registry

IRB Number: HUM 00049896

Study Team:

Principal Investigator:
Khanna, Dinesh; Department of Internal Medicine, Division of Rheumatology, Scleroderma Program, University of Michigan

Co-Investigators:
Schiopu, Elena, MD; Department of Internal Medicine, Division of Rheumatology, Scleroderma Program, University of Michigan

Phillips, Kristine, MD, PhD; Department of Internal Medicine, Division of Rheumatology, Scleroderma Program, University of Michigan

Trivedi, Mona, MD; Department of Internal Medicine, Division of Rheumatology, Scleroderma Program, University of Michigan

Study Purpose:

Scleroderma can affect patients in several ways which include activities of daily living, quality of life, and increased healthcare costs. 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. With your permission, we will also be storing some of these specimens so that future testing may be done.  In addition, we hope to explore the impact of scleroderma on patients’ daily lives and medical care through various questionnaires to be filled out by study participants.

By looking at all of the areas mentioned in the previous paragraph, we hope to find out information about scleroderma that will help us to treat  future patients, develop new treatments and work toward a cure.

Who can take part in this study?

Patients with a diagnosis of scleroderma who are over 18 years old.

Study Procedures:

If you agree to participate, you will be asked to do the following once a year:

1) Allow us to record data related to your condition from your medical records

If you have scleroderma, we will record information about your disease that has been previously observed or tested by your doctor.  For example, if you have had a pulmonary function test we may record the results of that test in our study records so that we are able to use that information to figure out more about your disease and how it changes over time. 

2) Fill out questionnaires relating to your mental and physical health.

We will have you fill out questionnaires at each visit during the study.  If there isn’t time for you to fill them out during your visit, we will give you a stamped addressed envelope and just ask you to mail them back to us.  

3) Skin Biopsies

If you have scleroderma and agree to having optional skin biopsies, we will take up to four small (4mm) punch biopsies (4mm is about the size of the eraser of a pencil). Up to two of these biopsies may be from skin on your arm that is affected by SSc (usually the forearm) and up to two may be taken from an unaffected area of your skin (usually the upper arm).
The procedure for a punch biopsy is relatively simple and should not take very long. You will first receive a shot of numbing medicine.  Next, a small, sharp tool that looks like a tiny cookie cutter (punch) will be placed over the area of skin to be removed.  The tool will be pushed down, and then slowly rotated to remove a circular piece of skin. The skin sample will be lifted up with a tool called a forceps or a needle and then will be cut from the tissue below with sterile scissors. This is a small tissue sample and stitches are rarely needed. Pressure will then be applied to the site until the bleeding stops. The wound will then be closed with special tape (Steri-strips), and covered with a bandage or sterile dressing. You will feel a stinging pain when the numbing medicine is injected but you should not feel anything during the biopsy. There is a risk of a small scar resulting from the skin biopsy.

 
Punch biopsy procedure
4.) Optional additional samples
If you have a bronchoscopy or biopsy of your stomach lining as a part of routine care, we would like to be able to collect any extra fluid from the bronchoscopy and/or any extra tissue from the biopsy for additional scleroderma research.  This is optional.

Study Contact Information:
Monika Benedict-Blue, BSW, CCRP
Linda Briggs, PhD, MPT, CCRP

Mailing Address:
University of Michigan Scleroderma Program
24 Frank Lloyd Wright Drive
Lobby M, Ste 2500
Ann Arbor, MI  48106

Telephone:
(866) 628-9200

Study Status:
Currently Enrolling Patients
Informed consent required


 

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