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@lupusdmv.org or call (888) 787-5380 for more information.
BENLYSTATM approved by FDA in the treatment of lupus!
March 9, 2011 marked an important landmark for the lupus community. The FDA announced approval of BENLYSTATM, the first drug ever designed specifically for the treatment of lupus and the first drug approved for lupus in over 50 years. This represents the beginning of a new era of improved diagnosis, prevention, and treatment for lupus. The FAQs about BENLYSTATM covers several important questions that you may have about this new drug.
Overcoming Barriers to Drug Development in Lupus
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 toward the development of new drugs 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. More research is needed to identify a cause for lupus, develop more safe and effective treatments and, ultimately, find a cure for the disease.
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 DC/MD/VA 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. 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 near you. You can search for these trials on the government’s Listing of Clinical Trials. We keep a listing of 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
The ILLUMINATE research studies will evaluate how safe and effective an investigational study medication will be as a possible lupus treatment, when compared with placebo (inactive substance). Qualified individuals are those who have been diagnosed with systemic lupus erythematosus (SLE) and are 18 years of age or older. Participation in the ILLUMINATE research studies will last approximately one year.
For more information, contact us at info@lupusdmv.org or 202-787-5380.
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 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:
Marta M. Guerra, MS
212-774-7361
Betsy Cohn, AB
212-606-1214
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 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
This is an intervention study that evaluates the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5mg/day and 1mg/day) in active lupus arthritis patients. Laquinimod is an immunomodulating drug which is currently used in advanced stages of development for Multiple Sclerosis. Participants are given a daily dose of laquinimod to assess the tolerability and clinical effect of laquinimod in systemic lupus erythematosus patients with active lupus arthritis.
Study Enrollment Began: July 2010
Study Ends: March 2012
Contact:
David Wofsy
MD, University of California
San Francisco, Clinical Trails Center
A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients with Systemic Lupus Erythematosus
This is a randomized control intervention study to assess the efficacy of 200-mcg dose of CEP-33457 compared with placebo in patients with active systemic lupus erythematosus (SLE) as assessed by the proportion of patients achieving a combined clinical response using the SLE responder index (SRI) at week 24. 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.
Study Start Date: June 2010
Study End Date: September 2012
Contact:
Cephalon
1-877-237-4879
Phillip Kempf, MD
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, United States, 22205
Cephalon
1-877-237-4879
Phillip Kempf, MD
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, United States, 22205
Adult male and female patients with active systemic lupus erythematosus (SLE) or active dermatomyositis (DM) or polymyositis (PM) are subjected to intravenous doses of sifalimumab to evaluate the safety and tolerability of sifalimumab among participants who were previously treated with investigational product (sifalimumab or placebo) in one of the following sifalimumab clinical studies: MI-CP151, MI-CP152, or MI-CP179.
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Contact:
Annalisa Dialino-Felix 301-398-0000
Mark Williams 301-398-0000
This study is for adults male and female patients with active systemic lupus erythmatosus (SLE) with the purpose to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in patients with active SLE. Two groups with be administered the experimental drug LY2127399 (one group every two weeks, the other every four weeks) as well as a placebo group every two weeks. Participants should note that because this is a study involving a placebo, there is a chance they may receive the placebo rather than the experimental drug.
Estimated Study Start Date: January 2011
Estimated Study Completion Date: Februrary 2014
Contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
This study is for adults male and female patients with active systemic lupus erythmatosus (SLE) with the purpose to confirm the clinical efficacy of epratuzumab in the treatment of subjects with (SLE). Two groups with be administered the experimental drug epratuzumab (one group 600mg every week, the other 1200mg every other week) as well as a placebo group every week. There will be a total of 4 weeks of dosage administration over a period of 12 week treatment cycles. Participants should note that because this is a study involving a placebo, there is a chance they may receive the placebo rather than the experimental drug.
Current Ongoing Study
Estimated Study Completion Date: February 2014
Contact:
UCB Clinical Trial Call Center +1 877 822 9493
This study is for adults male and female patients with active systemic lupus erythmatosus (SLE) with the purpose to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE. Three groups will be administered the experimental drug A-623 (high dose weekly, low dose weekly, high dose every 4 weeks) as well as a placebo group.Participants should note that because this is a study involving a placebo, there is a chance they may receive the placebo rather than the experimental drug.
Current Ongoing Study
Estimated Study Completion Date: May 2012
Contact:
Georgina Kilfoil
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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.