11 results
The study objective is to evaluate the clinical outcome of percutaneous aortic valve implantation in consecutive *real world* patients with severe aortic valve stenosis intended to be treated with the Medtronic CoreValve System.
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
ALZ-801 is an oral agent that is being developed as a potential disease modifying treatment for AD. This 78-week Phase 3 study will focus on Early AD subjects who carry the APOE4/4 genotype, and is designed according to current regulatory guidance…
The objective of this trial is to characterize annually the safety and durability data through 10 years in a subset of subjects randomized in the SURTAVI trial.
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.
The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…
The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial tissue as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.
Objectives - Core StudyPrimary Objectives• To evaluate the effects of oral ALZ-801 in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the plasma biomarkers of core AD pathology and brain volumes* Primary Plasma Biomarker Outcome…