13 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.
Primary Objective:To investigate the safety and tolerability of JNJ-42847922 in subjects with MDD. Study medication will be administered for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other subjects.Secondary Objectives…
To evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at…
Primary objective is to assess in vivo neuroinflammation quantitatively in patients with sepsis. Secondary objective is to study whether differences in in vivo neuroinflammation are related to long term cognitive outcomes.
Primary ObjectiveTo evaluate the effect of JNJ-42847922 on sleep latency (latency to persistent sleep [LPS]) in MDD subjects, stably treated with an SSRI/SNRI, who suffer from insomnia.Secondary Objectives* To investigate the safety, tolerability,…
The purpose of this study is to see if JNJ-42847922 is useful for treating patients with insomnia without any other psychiatric disease. The safety of JNJ-42847922 will also be studied.
* 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: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.
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…
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 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 aim of the current study is to assess the feasibility, safety and efficacy of the Steam ablation System for eradication of short segment BE.