Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
OsteoporosisJuvenile Rheumatoid Arthritis5 moreThe purpose of this study is to evaluate denosumab as a novel treatment for bone loss in children treated with glucocorticoids for rheumatic disorders. This is a pilot Phase 1/2, randomized open-label, 12-month clinical trial of denosumab to assess its effect on bone resorption markers and bone mineral density (BMD) in children with rheumatic disorders, age 4 to 16 years, recruited within 1 month of starting a chronic systemic glucocorticoid regimen. Primary outcomes include suppression of bone turnover markers and safety assessments. Secondary outcomes include changes in bone density as measured by dual energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) densitometry at the radius and tibia.
Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
Cutaneous Lupus ErythematosusPart I: to investigate the efficacy of different sunscreens in the prevention of skin lesions following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in patients with CLE. Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in the skin of patients with CLE and of Healthy Controls following UV irradiation.
Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThis 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.
The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS
Systemic Lupus ErythematosusThe main objective of study PLUS is to determine the potential benefits of individualized HCQ dosing schedules aimed at maintaining the whole-blood HCQ concentration above 1000 ng/ml
Study of Epratuzumab in Systemic Lupus Erythematosus
Systemic Lupus ErythematosusEpratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus...
AtherosclerosisThromboembolism1 moreThe purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
Triptorelin for Ovary Protection in Childhood Onset Lupus
Systemic Lupus ErythematosusThe purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
Lupus ErythematosusSystemicThe main objective of this study is to assess the safety, tolerability and pharmacokinetics of orally administered BI 705564 in patients with systemic lupus erythematosus
Establishing Clinical Utility of a New Diagnostic Test for Rheumatology Patients
Lupus NephritisLupus Erythematosus1 moreThis study will collect high-quality randomized controlled data from a nationally representative sample of practicing rheumatologists to determine how they currently manage patients with SLE (systemic lupus erythematosus) and how the results of DxTerity's IFN-1 (interferon type I) test change clinical decision making.
An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)
InflammationSystemic Lupus ErythematosusThis trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).