Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Systemic Lupus ErythematosusANCA Associated VasculitisLupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis
ANCA-associated VasculitisGranulomatosis With Polyangiitis2 moreThis prospective study will assess if 12 months of vitamin D3 (cholecalciferol) supplementation, in patients with AAV (GPA, MPA, and EGPA) who have deficient or insufficient 25(OH)D3 status at enrollment, correlates with improved disease activity and/or lower frequency of relapse (compared to historical data and a previously conducted cross sectional study (part I) that assessed vitamin D status in a cohort of similar patients).
Innovative Anti-pneumococcal Vaccine Strategies in Patients With ANCA-associated Vasculitis Receiving...
Invasive Pneumococcal InfectionThe study hypothesis is that a "reinforced" pneumococcal combined vaccine strategy in patients with ANCA-associated vasculitides treated with rituximab will induce a better immune response than the current standard regimen, with an acceptable safety profile. This study therefore aims at evaluating the immunogenicity and safety of two "reinforced" innovative pneumococcal vaccine regimen [one double dose at day0 and one double dose at day7 or a quadruple dose of 13-valent anti-pneumococcal conjugate vaccine (PCV13) followed by one dose of 23-valent unconjugated vaccine (PPV23) at month 5], compared to the standard regimen (one dose of PCV13 followed by one dose of PPV23 at month 5), in patients with ANCA-associated vasculitides receiving rituximab therapy.
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.
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 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.