10 results
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
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.
Primary: To describe safety and tolerability during longer-term administration of AR101 and follow-up observation after the last dose of AR101.Secondary: - To assess the level of desensitization achievable through extended maintenance dosing of…
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…
* 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 Objective:To verify the accuracy and performance of the GlycostatTM System including its ability to secure good glycemic control by means of its algorithm. The accuracy of Glycostat, expressed by MARD (Mean Absolute Relative Difference), the…
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.
Primary Objective:To determine if the time in the desired glycemic range is equivalent by following the insulin infusion rate advice from the Glycostat algorithm compared to historical data in the ICU. The historical data for glycemic control…