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Current Studies Seeking Volunteers

Systemic Lupus Erythematosus

Intervention to Improve Quality of Life in African American Lupus Patients
The goal of the proposed project is to enhance the Principal Investigator's research ability to conduct behavioral interventions for people with lupus. This includes intervention design, implementation, data collection and data analysis. The Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a uniquely tailored intervention program can improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African American lupus patients. This study builds on three decades of work conducted in the field of arthritis self-management but differs in that the intervention mode, the disease (lupus), and the study population (African-Americans) are unstudied or understudied. The IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its theoretical framework. This program has three specific aims. The first aim seeks to design a three armed randomized, wait list controlled trial that employs a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them to choose as many or few as they wish. The second aim is to assess the intervention, using the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use previously collected data to characterize patient-centric barriers to care in African-American lupus patients, in order to identify trends in patient needs and desires, as well as correlates of non-response and non-compliance that can be used in the development and refinement of the intervention.

Preventive Approach to Congenital Heart Block With Hydroxychloroquine
This Phase II study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of a heart condition called congenital heart block in the fetus. This heart problem is thought to be caused by autoantibodies some women with lupus produce to proteins called SSA/Ro and or SSB/La. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study plans to enroll 19 patients in the first year. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that less than 3 cases of heart block will occur. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy. The trial is sponsored by New York University School of Medicine.

Prospective Study of Rapamycin for the Treatment of SLE
The purpose of this Phase 2 study is to determine the effectiveness of Rapamune and how it works as a treatment for patients with SLE. Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent rejection of organ transplants. Patients that were resistant or intolerant to conventional medication have been effectively treated with Rapamycin and were able to decrease the amount of the corticosteroid prednisone that they needed. Sponsored by the State University of New York, Upstate Medical University the study will lasts one year; 40 SLE patients 18 years and older and 40 healthy volunteers are being recruited. The study drug, Rapamune, is manufactured by Pfizer Pharmaceuticals.

Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
This 12-week observational study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay that can detect if there is a problem with a protective shield on the surface of cells involved in abnormal blood clotting. To participate patients must be 18-65 years of age with persistent Antiphospholipid Syndrome and about to begin treatment with hydroxychloroquine. Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood. The study sponsor is Hospital for Special Surgery in New York.

Genetic Study of Lupus Patients and Their Families 
Little is known about the genetic factors that predispose people to developing SLE. Genes in patients with SLE may provide clues about SLE's pathogenesis. This study will compare genes from SLE patients, their unaffected family members, and control participants. Travel to the study site is not required. In this study, blood samples will be collected from people diagnosed with SLE, their unaffected family members, and condition-matched controls. Participants will be asked questions about their health and will provide a small blood sample. Participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. Study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases (LUPRON)
The purpose of this Phase III study is to determine whether the use of the gonadotropin releasing hormone (GnRH)-agonist leuprolide acetate (Lupron) during cyclophosphamide therapy in women with rheumatic diseases (such as lupus) will provide greater ovarian protection than placebo. As a gonadotropin release hormone agonis, Lupron is a type of medication that suppresses ovulation by stopping the production of the hormones estrogen and progesterone. Cyclophosphamide is a type of drug known as a disease-modifying anti-rheumatic drug (DMARD), which dampens down the immune system. Patients will be women ages 18-40 with either a severe rheumatic disease or interstitial lung disease requiring treatment with requiring cyclophosphamide. Sponsored by the National Institutes of Health, this trial lasts six months. Approved as a treatment for several other diseases, Lupron is in development by Abbott as a possible treatment in lupus.

Estrogen and Gender Biased Autoimmunity 
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus 
This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS) (PROMISSE)
The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The patients are followed regularly during the course of the pregnancy, collecting medical and obstetrical information as well as serial blood specimens for complement and cytokine assays. The data obtained will be analyzed and used to identify mechanisms and predictors of poor fetal outcome. We expect that the insights provided through this study will suggest means to prevent, arrest or modify these conditions.

Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus 
This trial is designed to evaluate the safety of treating systemic lupus erythematosus participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. There will be no randomization in this study. All subjects who are determined to be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus (ADDRESS II)
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy and safety of atacicept in patients with systemic lupus erythematosus (SLE).

Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome 
Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid antibodies, which are proteins in the blood that interfere with the body's ability to perform normal blood clotting. Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs, stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS have a genetic predisposition for developing the syndrome. This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder, such as lupus or rheumatoid arthritis.

Hematopoietic Stem Cell Support in Vasculitis 
In spite of modern therapeutic immune suppressive agents, there remains a not inconsequential morbidity and mortality associated with systemic necrotizing vasculitis (SNV). The current standard therapy for SNV is chronic oral cyclophosphamide (1-3 mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg infused over 4 days is the most common worldwide transplant regimen for systemic lupus erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We, therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG) for patients with SNV.

Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis 
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 40 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 2 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.


Cutaneous/Discoid

To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus  
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050. Patients must be at least 18 and be diagnosed with Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus among other criteria including active skin lesions. The study lasts 12 weeks; three out of four patients will receive the investigational drug. CC-11050 is an oral anti-inflammatory compound in investigation by Celgene.


Lupus Nephritis

ATLAS - Anti-Tweak in Lupus Nephritis Patients
This Phase 2 study is designed to evaluate the efficacy, safety, and tolerability of BIIB023 in treating lupus nephritis (kidney disease associated with lupus). BIIB023 is a human monoclonal antibody in development by Biogen Idec. To participate, patients must be 18 to 75 years of age, have been diagnosed with systemic lupus erythematosus and at least Class III level of lupus nephritis (kidney disease). Patients will be randomly selected for treatment with either of two doses of BIIB023 plus standard therapy or standard therapy and placebo. Safety, effectiveness and side effects of BIIB023 will be measured up to 72 weeks.


This information does not represent 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 LupusTrials.org for information on these studies. Only contact the listed numbers. LupusTrials.org does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.