One of the S.L.E. Lupus Foundation's goals is to bring the most up-to-date information to patients on the exciting developments in research and clinical trials for new treatments. Clinical trials, which involve patients themselves, are critical in the search for a better life for people with lupus.

In recent years, more and more pharmaceutical and biotech companies have developed new lupus treatments and are conducting clinical trials. That's why it is important to be informed about the clinical trial process and carefully weigh the pros and cons of participating in one.

Potential benefits to a person with lupus include access to new research treatments before they are widely available, and (typically) expert care at a leading health care facility aware of the latest in lupus advances. There's also the personal satisfaction of helping science find answers. (See also "Observational Studies," below.)

There are often risks, however. The potential hazards of a treatment may be unknown. Side effects may be serious or unpleasant. In addition, a treatment intended to improve a condition may end up doing nothing.

What You Need To Know
There are many resources available to help you decide if participating in a clinical trial is right for you:

• Read "Why You Should Care About Clinical Trials" from the November/December 2006 issue of The Cooperative Corner, the newsletter of the Lupus Cooperative of New York.
• Our partner organization, the Lupus Research Institute, has developed an LRI Patient Resource Guide (PDF) that answers frequently asked questions concerning clinical trials.
• Personal stories of people who have participated in clinical trials can be very revealing. California mom (PDF) Tracy Mynhier, a wife and mother of four, shares her experience.

Where To Find Clinical Trials

• www.clinicaltrials.gov Government-sponsored lupus clinical trials are listed here. On the site you will find information on the purpose of the trial, who is eligible, trial locations, and contact information.
• Clinical Trials Resource Center. This extended list of clinical trials and other resources is provided in partnership with CenterWatch.

SLE Lupus Foundation List of New York-Area
Clinical Trials

If you are interested in volunteering for a study, please contact the study coordinator directly.

Manhattan:

RITAPS: A Pilot Study Of Rituximab For The Anticoagulation-Resistant Manifestations Of Antiphospholipid Syndrome (APS) 
Sponsors: Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery, Genentech
Seeking Volunteers: Patients are eligible to take part in this study if their blood test is persistently positive for antiphospholipid antibodies (aPL) and they have one or more of the following aPL-related clinical problem(s): Low Platelet (blood cells involved in the prevention of bleeding) Count; Anemia (deficiency of red blood cells); Heart Valve Disease; Skin Ulcers; Kidney Smal Vessel Blood Clots; and/or Memory Problems.
Contact: JoAnn Vega: 212-774-7615 - vegaj@hss.edu or Vidh Tyagi: 212-774-2808 - tyagiv@hss.edu

Manhattan:

Antiphospholipid Syndrome Collaborative Registry (APSCORE)
Sponsor: National Institutes of Health/NIAMS, Bethesda, MD
Seeking Volunteers: People with antiphospholipid antibodies to join a national disease registry.
Contact: Gail Buxton: 919-966-0572; 800-411-1222; or email apscore@med.unc.edu

Manhattan:

Epratuzumab in Systemic Lupus Erythematosus - Pharmacokinetics Study
Sponsor: Immunomedics, Inc.
Seeking Volunteers: Persons age 18 and above who have had SLE for at least 6 months prior to study, has at least one elevated autoantibody at study entry, and has moderately active SLE disease at study entry.
Contact: Heather Horne 973-727-7589

Manhattan:

Treating Systemic Lupus Erythematosus (SLE) Patients with CTLA4-IgG4m (RG2077)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID), Immune Tolerance Network
Seeking Volunteers: Persons age 18 and above with lupus nephritis. Also, people with SLE and on concurrent treatment with intravenous cyclophosphamide for certain manifestations of lupus. Also: stable medication regiment for at least 4 weeks prior to study entry, weight between 88.2 lb and 275.6 lb, and willing to use acceptable forms of contraception.
Contact: 212-305-9986

Manhattan:

A Study to Evaluate the Safety and Effectiveness of Edratide in the Treatment of Lupus (Phase II)
Sponsor: Teva Neuroscience
Seeking Volunteers: Men and women between ages 18 and 65 years who fulfill at least 4 critera for SLE.
Contact: Shared Solutions 1-866-550-0614.

Manhattan:

The Research Registry for Neonatal Lupus
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases
Seeking Volunteers: Mothers with antibodies to SSA/Ro, SSB/La, or RNP, or child of mother with such antibodies who has neonatal lupus, or father of neonatal lupus-affected child or maternal grandparents of neonatal lupus-affected child or aunts and uncles of neonatal lupus-affected child.
Contact: Peg Katholi at 212-598-6514; peg.katholi@nyumc.org

Manhattan:

Triptorelin for Ovary Protection in Childhood Onset Lupus
Sponsor: FDA Office of Orphan Products Development
Seeking Volunteers: Females between ages 9 and 21 years, not pregnant, who have lupus and are newly requiring IV cyclophosphamide.
Contact: Hermine Brunner, MD. 513-636-7275; hermine.brunner@cchmc.org

Manhattan:

New Drug That May Protect Function of Reproductive Organs in Girls Receiving Cyclophosphamide for Lupus
Sponsor: FDA Office of Orphan Products Development
Seeking Volunteers: Females who have been diagnosed with Systemic Lupus Erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease.
Contact: Lisa F Imundo, MD 212-305-9304; lfi1@columbia.edu

Manhattan:

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Sponsors: Hospital for Special Surgery, NIAMS, Alliance for Lupus Research
Seeking Volunteers: Pregnant women who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE.
Contact: Silvia H. Norbis, AB 212-606-1214; norbiss@hss.edu
Marta M Guerra, AB, MS 212-774-7361; guerram@hss.edu

Manhattan:

Memory and Attention Problems in Lupus: New Treatment Trial with Modafinil
Sponsor: Hospital for Special Surgery
Seeking Volunteers: SLE patients at the Hospital for Special Surgery with functional difficulties due to cognitive dysfunction.
Contact: Daniel M Horn, BA 212-606-1867; hornd@hss.edu
Claudia M. Reuben, BS 212-606-1867; reubenc@hss.edu

Manhattan:

Health-Related Quality of Life Measure in Pediatric Lupus
Sponsors: University of Medicine and Dentistry New Jersey , Hospital for Special Surgery, New York, St. Barnabas Medical Center, Hackensack University Medical Center, La Rabida Children's Hospital, Pfizer
Seeking Volunteers: Children ages 2 through 18 with SLE.
Contact: Lakshmi N Moorthy, MD, MS 732-235-4980 moorthln@umdnj.edu
Maria J Baratelli, BA 732-235-6555 baratemj@umdnj.edu

Manhattan:

Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns with Lupus
Sponsor: NIAMS
Seeking Volunteers: Mother must have anti-Ro and/or anti-La antibody, Fetal bradyarrhythmia (slow, abnormal heart rhythm)
Contact: Claudine Davis 212-598-6513 prideinchb@yahoo.com
Jill P. Buyon, MD 212-598-6522 jill.buyon@med.nyu.edu

Manhattan + Brooklyn + Lake Success + Syracuse

Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination with Prednisone
Sponsor: Bristol-Myers Squibb
Seeking Volunteers: Subjects must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit and be on a stable dose of prednisone (<30mg) for at least one month.
Contact: BMS Call Center 1-866-892-1BMS Ext. 175

Manhattan + Albany + Rochester

A Study to Evaluate the Efficacy and Safety of Rituximab in Patients with Severe Systemic Lupus Erythematosus (Phase 11 + Phase 111)
Sponsor: Genentech
Seeking Volunteers: Men and women ages 16 – 75 with a lupus diagnosis and active disease.
Contact: Trial Information Support Line 888-662-6728.

Manhattan + Bronx, Brooklyn, and Other Locations

BLISS study (Belimumab International SLE Study)
Sponsor: Human Genome Sciences
Seeking volunteers: Age 18 or older with systemic lupus.
Contact: Dan Odenheimer, PhD at 1-866-447-9749 or dan_odenheimer@hgsi.com or visit www.bliss-study.com   

Brooklyn + Manhattan + Lake Success

ALMS—Aspreva Lupus Management Study of Mycophenolate Mofetil (MMF) in Lupus Nephritis. Sponsor: Aspreva Pharmaceuticals (as part of the Roche-Aspreva Collaboration Agreement)
Seeking Volunteers: Persons with a diagnosis of lupus nephritis requiring immunosuppressive therapy.
Contact: medinfo@aspreva.com

Bronx:

GL701 P(PrestaraTM) in Women with Systemic Lupus Erythematosus Receiving Treatment with Glucocorticoids (Phase III)
Sponsor: Genelab Technologies
Seeking Volunteers: Women age 18 and above who has completed the full 6 month treatment period with study drug in the previous clinical study of GL02-01.
Contact: Betty Quarles, B.Sc. 650-562-1425; bquarles@genelabs.com

Stonybrook:

Plaquenil for Alopecia Areata, Alopecia Totalis
Sponsor: Hordinsky, Maria K., MD
Seeking Volunteers: Men and women age 18 and above with severe alopecia areata (hair loss) or complete baldness.
Contact: Cathleen Boeck, RN 612-625-4973; boeck001@umn.edu
Richard Kalish, MD, PhD 631-632-9036; Richard.kalish@sunysb.edu

Disclaimer
This information does not represent a S.L.E. Lupus Foundation endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the S.L.E. Lupus Foundation for information on these studies. Only contact the listed numbers. The S.L.E. Lupus Foundation does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.

Observational Studies
Eager to help advance lupus research but unsure about participating in a clinical trial? Many lupus clinics and academic centers conduct so-called "observational studies" designed to follow the natural progression of the disease and gain crucial insight in to how lupus affects different organs. Unlike straightforward clinical trials, however, these types of studies do not involve taking new (extra) medications or therapies; you are simply seen by the participating doctor several times a year and may be asked to give extra blood samples or have certain tests done.

National Data Bank for Rheumatic Diseases Observational Study of Lupus

Sponsor: National Data Bank for Rheumatic Diseases

Seeking volunteers: All people with lupus. The NDB performs its research primarily by collecting information from people who have SLE. This is done by confidential mailed questionnaires or secure online web forms. NDB research is concerned with important issues for people with SLE: which treatments are most effective, symptoms, side effects and long term-outcomes. In addition, NDB is interested in medical costs, quality of life, ability to work and function, price of medications and the extent to which medical treatments actually improve people. Treatment is not affected. No medical visits are required.

To contact or learn more about the study, visit www.lupus-research.org

For more information on observational studies, ask your physician about studies taking place near you, or enter "lupus observational study" on www.clinicaltrials.gov.