Research and Clinical Trial Information

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.

BENLYSTA 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 BENLYSTA 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:

  • Read our FAQ on participating in clinical trials (PDF).
  • 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.
  • 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.
  • 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, Maryland & Virginina

The ILLUMINATE Program
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.

The EMBODY Program: Testing the safety and effectiveness of epratuzumab
The EMBODY program is a global clinical research program testing the safety and effectiveness of an investigational study drug called epratuzumab in people with moderate to severe lupus. To qualify for the EMBODY program, you must meet the following criteria: at least 18 years of age, diagnosed with systemic lupus erythematosus and not pregnant or nursing. If you agree to participate and meet the study criteria, your participation in the EMBODY program will last approximately one year.

Contact:
757-461-3400

3210 Churchland BLVD
Suite 112
Chesapeake, VA

Blood Component Collection From Patients With Rheumatic Disease
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
prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892

Genetic Analysis of Immune Disorders
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
prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892


Immune System Related Kidney Disease
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
prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892

Study of Families With Twins or Siblings Discordant for Rheumatic Disorders
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
prpl@mail.cc.nih.gov

National Institutes of Health Clinical Center
9000 Rockville Pike
Bethesda, MD, 20892

A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Subjects With Systemic Lupus Erythematosus or Myositis
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
 

Documents denoted with (PDF) require Adobe Acrobat software.

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.