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.
Targeting Complement Activation in Antineutrophil Cytoplasmic Autoantibodies (ANCA)-Vasculitis -...
Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisThe purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic Autoantibodies ) vasculitis and lead to a more rapid decrease in disease activity. ANCA vasculitis is an inflammation of the small vessels whereby ANCA antibodies inappropriately activate one's own white blood cells (neutrophils) and cause damage to the small blood vessels.
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Cardiac DiseaseDementia5 moreThis randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.
Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens
Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisThe purpose of this research study is to learn if adding all-trans retinoic acid (tretinoin) to conventional treatment of Anti- Neutrophil Cytoplasmic Autoantibodies (ANCA) vasculitis can decrease the level of disease activity.
Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National...
ANCA Associated VasculitisOccupational Diseases1 moreThe main objective is to identify specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the RNV3P data. The secondary objectives are as follows: Description of cases of ANCA vasculitis seen in French occupational pathology consultation centres: reasons for consultation, occupational and environmental etiologies described occupational situations responsible aptitude notices recognition as an occupational disease Identification of specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases). For occupational and non-occupational cases of ANCA vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations. Estimation of the number of applications for recognition of disabled worker status made within this patient group. Identification of clinical severity and autoimmune profiles of ANCA vasculitis of occupational and/or environmental origin.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants...
VasculitisSystemic Lupus Erythematosus (SLE)The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant...
Anti-neutrophil Cytoplasmic Antibody-associated VasculitisThe primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy participants.
A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
Anti-neutrophil Cytoplasmic Antibody-associated VasculitisThe objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 in Japanese healthy adult males; and to compare the pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 between Japanese and Caucasian healthy adult males.
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of...
Anti-neutrophil Cytoplasmic Antibody-associated VasculitisThe primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion)...
Anti-neutrophil Cytoplasmic Antibody-associated VasculitisThe primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.