Research - Lupus Foundation of America, Inc.

Research Studies

This list of research studies underway in this country has been divided into two groups, depending on whether the study is a study of a novel therapeutic (investigational drug) or merely requires information and/or blood samples from enrollees (clinical study). The information on these pages is provided without implied recommendation, solely as a service to those who may be interested. As with all research projects, interested parties should thoroughly question and have a complete understanding of the work, and the involvement in and commitment to the study, before considering participation.

NOVEL THERAPEUTICS
Therapy & Sponsor/Site	Target Population	Contact Phone/E-mail
Allogenic Stem Cell Transplant in Severe SLE Northwestern University and Northwestern Memorial Hospital, Chicago, IL	Persons ages 18-45 with refractory/life threatening lupus; SLE with HLA matched sibling and Class III or IV glomerulonephritis, involvement of the lung or central nervous system, transfusion-dependent autoimmune cytopenias, refractory serositis or antiphospholipid syndrome	Kimberly Yaung (312) 503-1435 kyaung@nmff.org
ALMS - Aspreva Lupus Management Study of Mycophenolate Mofetil (MMF) in Lupus Nephritis Aspreva Pharmaceuticals (as part of the Roche-Aspreva Collaborative Agreement	Persons with a diagnosis of lupus nephritis requiring immunosuppressive therapy	Please visit www.almstudy.com or call (512) 685-5662
Anti-CD4 Monoclonal Antibody (TRX1) to Treat Cutaneous Lupus	Persons between the ages of 18 and 60 with refractory (not responsive or responding to medication) Cutaneous Lupus Erythematosus (CLE ) are needed to participate in a research study. There is no charge for study visits. Study visits take place over a 14 - week period. Qualified subjects may be compensated for time and travel required. Two overnight stays in the clinic are required.	Tyler, TX Lynne Stein (903) 534-6200 Palo Alto, CA Valerie Ojha (650) 724-0385 Portland, OR Marguerite Mesa (503) 245-1525 New York, NY Margaret Andrew (212) 998-9626
Atorvastatin (Lipitor) for Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Duke Medical Center/Duke Clinical Research Institute, Durham, NC NIAMS/NIH, Bethesda, MD	Persons between ages 10 and 21 (at least 55 lbs) and diagnosed with childhood onset SLE; able to complete self-report questionnaires in either English or Spanish	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Autologous Stem Cell Transplantation and High-Dose Immunosuppression University of California, San Diego	Persons with SLE who are candidates for Cytoxan	Sue Corringham (858) 822-6387
CD40 Ligand (CD154) in in Gene Regulation in SLE NCRR/NIH, Bethesda, MD	Persons with SLE and healthy individuals	Randy Q. Cron, Ph.D. (215) 590-1844
CTLA4-Ig Used With Cyclophosphamide to Treat SLE: Phase I/Phase II Study NIAID/NIH, Bethesda, MD+A9 Immune Tolerance Network	Persons age 18 and older with SLE who are currently receiving cyclophosphamide	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
A Phase I Pilot Study on High Dose: Cyclophosphamide, Fludarabine, and CAMPATH followed by T-cell Depleted Autologous Stem Cell Rescue for Patients with Systemic Lupus Erythematosus (SLE)	Patients with SLE and renal, pulmonary or central nervous system involvement.	Lynn Ghent Penn State University, Milton S. Hershey Medical Center 717-531-6012 weblink
Dexamethasone Treatment for Congenital Heart Block in Newborns With Lupus NIAMS/NIH, Bethesda, MD	Two-part study (observational and interventional): Pregnant women ages 16 to 50, either asymptomatic or with any rheumatic disease, whose baby has fetal heart block	Elaine Kiang (212) 598-6513
Epratuzumab in Active SLE or with Acute Severe SLE Flares Immunomedics, Inc.	Persons who have had SLE for at least 6 months with at least one elevated lupus-associated antibody and new onset severe lupus disease flare in at least one organ/system (Alleviate A) OR moderate lupus disease flare in several body organs/systems (Alleviate B) (renal and neurologic systems excluded)	Sally Klemm, R.N. (973) 605-8022
Epratuzumab in SLE: Study of Pharmacokinetics/ Pharmacodynamics Immunomedics, Inc.	Persons age 18 and older with moderately active SLE for at least 6 months and at least one elevated autoantibody level	Heather Horne (973) 727-7589
Explorer Study for Lupus Genentech	Persons between ages 16 and 75 with SLE only, currently being treated with an immunosuppressive drug	1-877-5TRIALS (1-877-587-4257) www.LupusTrial.com/lupus
GL701 (Prestara) in Women with SLE Receiving Treatment with Glucocorticoids Genelabs Technologies	Females with SLE who have completed the full 6-month treatment period with study drug in the previous Genelabs' clinical study GL02-01 and have had concomitant treatment with prednisone (or equivalent) at a dose of = 5mg/day	Betty Quarles, B.Sc. (650) 562-1425, bquarles@genelabs.com Kenneth Schwartz, M.D. (650) 562-1510, kschwartz@genelabs.com
High Dose Immunotherapy and Autologous Stem Cell Transplantation in Severe SLE: Conditioning Regimen of Cyclophosphamide and CAMPATH Northwestern University and Northwestern Memorial Hospital, Chicago, IL	Persons with for refractory/life-threatening lupus; Class III or IV glomerulonephritis, involvement of the lung or central nervous system, transfusion-dependent autoimmune cytopenias, refractory serositis or antiphospholipid syndrome	Kimberly Yaung (312) 503-1435 kyaung@nmff.org
Immune Ablation and Autologous Hematopoietic Stem Cell Support Using High-dose Cyclophosphamide and ATG Northwestern University and Northwestern Memorial Hospital, Chicago, IL	Persons with for refractory/life threatening lupus; Class III or IV glomerulonephritis, involvement of the lung or central nervous system, transfusion-dependent autoimmune cytopenias, refractory serositis or antiphospholipid syndrome	(312) 503-1435 kyaung@nmff.org
LJP 394 ( Riquent ) for Lupus Nephritis La Jolla Pharmaceutical Company	Persons ages 12 - 70 with active lupus kidney disease within past 4 years; must be able to have weekly intravenous study treatment	David Conway 858-452-6600 ClinicalTrials.gov #NCT00089804
Rituxan (rituximab, anti-CD20) Genentech	Persons with moderate to severe SLE (Phase II/III study)	Sandy Chanoff Felicia Barnack (215) 662-4658 (215) 615-4306
Safety and Efficacy of Investigational Drug for SLE SLE and Autoimmune Disease Treatment Center, North Shore-LIJ Health System, Lake Success, NY	Persons with moderate to severe SLE who are taking methotrexate, azathioprine (Imuran®), or mycophenolate mofetil (CellCept®)	Richard Furie, M.D. (516) 708-2556
Safety and Efficacy of Investigational Drug for SLE SLE and Autoimmune Disease Treatment Center, North Shore-LIJ Health System, Lake Success, NY	Persons at least 18 years of age with active SLE, receiving corticosteroids (prednisone or equivalent, 7.5-20 mg/day) and either an immunosuppressant or antimalarial	Richard Furie, M.D. (516) 708-2556 Laura Donohue (516) 708-2556 ldonohue@nshs.edu
Sirolimus Therapy in Ideopathic and Lupus Membraneous Nephrology Wyeth-Ayerst Laboratories NIDDK/NIH, Bethesda, MD	Persons age 13 or older with persistent proteinuria	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Total Body Irradiation in Children With Refractory Autoimmune Disorders Fred Hutchinson Cancer Research Center, Seattle, WA	Persons between ages 2 and 18 with at least one ACR criterion for severe JRA, childhood onset SLE, SSC or dermatomyositis	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Triptorelin for Ovary Protection in Childhood Onset SLE FDA Office of Orphan Products Development	Females between ages 9 and 21, not pregnant, who have lupus and are newly requiring IV cyclophosphamide	Hermine Brunner, M.D. (513) 636-5484 hermine.brunner@cchmc.org
TV-4710 (Edratide) for the treatment of SLE, Teva Pharmaceutical Industries, Ltd.	Persons ages 18 to 65 with active, moderately severe SLE	Teva Call Center (866) 550-0614
Ultraviolet A-1 Light Therapy for SLE National Center for Research Resources Louisiana State University, New Orleans	Persons ages 15 to 70 with symptomatic SLE	Hugh McGrath, Jr., M.D. (504) 568-4609

CLINICAL STUDIES
Topic & Sponsor/Site	Target Population	Contact Phone/E-mail
African American Families with Lupus Oklahoma Medical Research Foundation Oklahoma City	Families with at least one member diagnosed with systemic lupus; may live in different parts of the country	Recruiting Staff (888) 655-8787 (405) 271-7479 email: lupus-recruiters@lupus.omrf.org
Antiphospholipid Syndrome Collaborative Registry (APSCORE) NCMHD and NIAMS/NIH, Bethesda, MD	Persons with antiphospholipid antibodies	Robert S. Roubey, M.D. Gail Buxton (919) 966-0572 (800) 411-1222 apscore@med.unc.edu
Antiphospholipid Syndrome Registry Hospital for Joint Diseases, New York City Oklahoma Medical Research Foundation, Oklahoma City	Persons with APLS and their family members for a study of causes and blood clotting risk factors	Ranit Shriky, CCRC (866) 757-2757 Joan T. Merrill, M.D. (405) 271-7805
Cognitive Function in SLE National Jewish Medical and Research Center University of Colorado Health Sciences Center, Denver	Persons ages 18 to 50 with SLE who live in Denver area	Marie Devore (303) 398-1141 D28devorem@njc.org
Dental Screening for Systemic Diseases or Oral Diseases NIDCR/NIH, Bethesda, MD	Persons of any age who have oral diseases or systemic diseases of the upper jaw and face (such as SLE, lichen planus or premalignant oral leukoplakia)	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Environmental and Genetic Causes of Rheumatic Diseases NIEHS/NIH, Bethesda, MD	Persons with a diagnosis of rheumatoid arthritis, myositis, lupus and scleroderma, and healthy volunteers of all ages	Mark Gourley, M.D. (301) 451-6280
Families with Twins or Siblings Discordant for Rheumatic Disorders NIEHS/NIH, Bethesda, MD	Twin pairs or sibling pairs with diagnosed with a systemic rheumatic disorder (RA, JRA, SLE, SSc, or IIM); genetic fathers and mothers; normal healthy volunteers as controls	Patient Recruitment & Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Genetics of Lupus Project University of California San Francisco	Persons with lupus; may live anywhere in the country	Lindsey A. Criswell, M.D., M.P.H. or Recruiting Staff (888) 223-3067 ramosb@medicine.ucsf.edu
Genetic and Clinical Risk Factors for Lupus Nephritis Ohio State University Medical Center, Columbus	Persons with lupus and their parents (or siblings)	Lee Herbert, M.D. Amy Aziz, M.D. Brad Rovin, M.D. (614) 293-4997 (800) 818-0241
Lupus Multiplex Registry & Repository Oklahoma Medical Research Foundation, Oklahoma City, OK	Families in which one or more living members have been diagnosed with SLE; must live in the U.S., Canada, Puerto Rico, or the Virgin Islands	Recruiting Staff (800) 655-8787 (405) 271-7479 lupus-recruiters@lupus.omrf.org
Lupus Outcomes in Minority Populations (LUMINA) University of Alabama, Birmingham; University of Texas Health Sciences Center, Houston; and University of Puerto Rico Medical Sciences Campus	Persons who have had lupus less than five years and live in geographic areas of Birmingham, Houston or San Juan, Puerto Rico	Alabama: Graciela S. Alarcón, M.D., M.P.H., (205) 934-2799 (205) 934-4084 Texas: John D. Reveille, M.D. (713) 500-0523 Puerto Rico Luis M. Vilá, M.D. (787) 758-2525 (ext: 1834/1825)
Multiple Autoimmune Disease Genetics Consortium (MADGC) North Shore University Hospital, Manhaset, NY, University of Minnesota, Minneapolis, MN	Families with at least two members who have any two or more of the following: SLE, RA, MS, autoimmune thyroid disease, type 1 diabetes	(877) 698-9467
Neonatal Lupus Research Registry NIAMS/NIH, Bethesda, MD	Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins OR child who has neonatal lupus whose mother has these antibodies OR father, maternal grandparents, aunts or uncles of neonatal lupus-affected child	Peg Katholi (212) 598-6514 peg.katholi@nyumc.org
Gene Mapping in Women with SLE NIAMS/NIH, Bethesda , MD	Anyone with a diagnosis of SLE (Travel to the study site is NOT required)	Laurie Kyle (800) 515-8787 recruiter@lupusstudy.org www.lupusstudy.org ClinicalTrials.gov #NCT00235378
Parenting and the Impact of Symptoms of SLE or Scleroderma	Mothers who have been diagnosed with SLE or scleroderma who have children up to age 18 years living at home	Janet Poole, Ph.D., OTR/L 1-800-922-5015 jpoole@salud.unm.edu Cindy Mendelson, Ph.D, R.N. 505-272-8141 cfmendelson@salud.unm.edu

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Updated 11-27-2006