Research
The Lupus Foundation of America, DC/MD/VA Chapter needs your support to continue funding and supporting new research and drug development activities. You can support lupus research by donating to lupus research efforts or participating in a clinical trial. Please email info@lupusgw.org or call (888) 349-1167 for more information.
Overcoming Barriers to Drug Development in Lupus![]()
It was 50 years ago that a drug specifically to treat lupus was approved. The Lupus Foundation of America’s (LFA) campaign, Zero in 50™ was launched to raise public awareness, and call attention to the urgent need for safer, more tolerable, and effective lupus treatments. More research is needed to identify a cause for lupus, develop more safe and effective treatments and, ultimately, find a cure for the disease.
A recent report commissioned by the LFA entitled “Overcoming Barriers to Drug Development in Lupus” (PDF) and prepared by the Lewin Group examined the obstacles to developing new lupus drugs and the effect on people living with lupus.
The report found that a major obstacle to new drug development is the way that lupus may present itself differently in each case. Because lupus symptoms wax and wane, it may be difficult for researchers to identify when a person has lupus and what the severity of his or her disease is. This fluctuation of symptoms, along with the symptomatic complexity and variety, makes choosing clinical endpoints difficult, so it is difficult for researchers to make definitive statements about the efficacy of new drugs.
Following the report’s recommendations, the LFA encourages federal agencies, academic institutions, private industry, and the lupus scientific community to collaborate in an effort to develop more effective treatments for lupus. The LFA hopes that the recommendations set forth by the report will help inform the policy and practice of clinical trials in the future, with the goal of developing new drugs to treat lupus.
Supporting LFA’s National Research Program
The DC/MD/VA Chapter contributes to LFA’s National Research Program, Bringing Down the Barriers. This lupus research program is unique because it not only funds basic and clinical research, but also focuses on areas that have been inadequately funded by the federal government, industry, or other organizations. LFA funds research that addresses issues of critical importance for people with lupus, including the management of the disease in children and teens, improving health outcomes, the underlying genetic causes of male lupus, facilitating greater accuracy in the diagnosis of lupus, and the development of new, safe, and effective treatments.
As part of its ongoing commitment to bring down the barriers that have obstructed research on lupus, the LFA and its affiliated chapters have provided $22 million to fund more than 400 grants to investigators at approximately 100 leading academic and medical institutions throughout the nation. Funds from the Greater Washington Chapter were directly channeled into research on diagnostic criteria in Baltimore, MD led by Michelle Petri, M.D., M.P.H. at Johns Hopkins Medical Institutions.
Clinical Trials
Clinical trials use volunteer patients to investigate and study different treatments for disease. A clinical trial study tries to answer questions about prevention, treatment and diagnosis of a disease such as lupus. There has not been a new drug developed for the treatment of lupus in over 50 years. Some of our lupus patients see their participation in clinical trials as a way that they can help change that fact. Clinical trials are important because they contribute to the overall knowledge in a field and progress made toward understanding and developing therapies for a particular area of medicine. Educate yourself about lupus clinical trials at LFA's Center for Clinical Trials Education.
From time to time, clinical trials which need lupus patients to participate are offered right here in the Greater Washington area. You can search for these trials on the government’s Listing of Clinical Trials. We will also keep a listing of most of these trials below.
Making the Decision to Participate in a Clinical Trial
Participation in a clinical trial is a personal decision that should be made with your doctor. If you are interested in participating in a trial, we recommend the following steps:
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Talk to your doctor. Your doctor may be aware of the drug or the therapy in the trial and can help you weigh the risks and your potential eligibility.
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Talk to the trial coordinator. This is the person who can talk to you or your doctor and determine the state of your health and your eligibility for the trial.
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Set up a pretrial screening. You will go through various tests to determine your eligibility. This screening should give you a chance to talk to the investigators and learn more about the trial and what the researchers are looking for.
Current Clinical Trials in DC, MD & VA
This is an observational study that analyzes white blood cells from patients with rheumatic diseases such as lupus. Participants will give a blood sample that will be used in studies comparing the number and function of similar cells from patients with rheumatic diseases, focusing on the differences in number and function of the cells in health and disease.
Study Start Date: February 2002
Study End Date: Ongoing
Contact:
Patient Recruitment and Public Liaison Office
1-800-411-1222
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892
The purposes of this study are to identify the genes responsible for certain immune disorders, learn about the medical problems they cause, and learn how to predict who is likely to develop these disorders and what the risk is of passing them on to children. Participants will provide a small blood sample for genetic (DNA) and white blood cell analysis. Gene samples may also be obtained by mouth brushing or skin biopsy.
Study Start Date: January 1995
Study End Date: Ongoing
Contact:
Patient Recruitment and Liaison Office
1-800-411-1222
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892
This is an ongoing study being conducted at the National Institutes of Health which evaluates lupus patients and their relatives to determine how the disease changes over time. There is no treatment associated with this study, but participants’ physicians will be offered treatment advice and participants will be screened to see if they qualify for other studies with experimental treatment options.
Study Enrollment Began: February 1994
Study Ends: Ongoing longitudinal study with no set end date
Contact:
Patient Recruitment and Liaison Office
1-800-411-1222
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892
This study for pregnant women between ages 18 and 45 is aimed at determining if lupus patients with elevated blood protein levels are at higher risk for pregnancy complications. Women participating in this study will have their blood measured for protein and anti-angiogenic (blood vessel-producing) levels.
Study Enrollment Began: September 2003
Study Ends: August 2013
Contact:
Ehtisham Akhter, M.D.
410-614-1573
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
This study examines people with autoimmune-related kidney diseases, including lupus. Participants will undergo a physical and medical history, then possibly blood and urine samples at future follow-up visits.
Study Enrollment Began: April 1992
Study Ends: Ongoing longitudinal study with no set end date
Contact:
Patient Recruitment and Liaison Office
1-800-411-1222
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892
This study is taking place at Georgetown University Hospital. It will involve a standard evaluation of patients with non-healing leg ulcers evaluated in the Georgetown Division of Rheumatology, including an initial history and physical examination, along with hypercoagulable and autoimmune profiles. If this is your first visit to the rheumatology clinic the initial laboratory testing will require 3.5 tablespoons of blood. The investigative team will ask for your permission to review your medical record for previous blood test results so that you do not undergo unnecessary testing. There is no treatment involved in this study and you must have health insurance to participate.
Study Enrollment Began: August 2007
Study Ends: August 2010
Contact:
Victoria K Shanmugam, MD
1-202-687-8233
Georgetown University Hospital
Washington, DC, 20007
This study is for people with lupus who are intolerant of statin drugs used to reduce certain blood proteins. Participants will instead be given doxycycline to reduce these blood proteins. Participants should note that because this is a double-blinded placebo study there is a chance that they will be given a placebo instead of the experimental drug (doxycycline).
Study Enrollment Begins: April 2010
Study Ends: December 2010
Contact:
Michelle Petri, M.D.,M.P.H
410-955-3823
Johns Hopkins University SOM.
1830 East Monument St, Ste 7500
Baltimore, Maryland, 21205
This study is taking place at two rheumatology offices in Maryland and will evaluate the efficacy and safety of rontalizumab, a monoclonal antibiotic, in the treatment of moderate to severe Systemic Lupus Erthyematosus. By participating in this study you consent to a double-blind placebo-controlled study, meaning that it is possible you may receive a placebo instead of rontalizumab, the drug being tested.
Study Enrollment Began: August 2009
Study Ends: September 2012
Contact:
Lynn Metcalf
1-301-724-4337 ext 14
Klein & Associates, M.D. P.A.
Cumberland, Maryland, U.S.A, 21502
Or
Kelly Weicht
1-301-791-6680
Klein & Associates, M.D. P.A.
Hagerstown, Maryland, U.S.A., 21740
This study examines the environmental factors which go into rheumatic disorders, including lupus, by examining siblings in which one has lupus and the other does not. Participants in this study will have blood and urine collected and may have their medical histories examined. Additionally, people with lupus may be asked if their siblings and parents may be contacted to have blood drawn for comparison.
Study Enrollment Began: February 2003
Study Ends: Ongoing enrollment, requires 5 year participation
Contact:
Patient Recruitment and Liaison Office
1-800-411-1222
National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892
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The Lupus Foundation of America, DC/MD/VA Chapter is proud to be a source of
information on lupus. Our comments are based on professional advice, published experience
and expert opinion, but do not represent individual therapeutic recommendation or prescription.
For specific information or advice, please consult your physician. If you need help finding a
physician, we maintain a list of physicians who treat lupus patients.