10 results
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
The aim of the study is twofold. The first is the impact of DRL-21994 and the registered product on the release of vessels studied and compared. The second is the speed with which DRL-21994 is included in the body examined, as well as the degree of…
PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…
Objectives:To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. The secondary objective is to…
The aim of the study is twofold. The first is the impact of the investigational drugs and the registered product on safety, tolerability and the release of vessels studied and compared. The second is the speed with which the investigational drugs…
The objective of this study is to assess the safety and efficacy of efalizumab combined with methotrexate compared with efalizumab monotherapy in adult patients (aged > 18 years) with moderate to severe psoriasis.
The primary objectives are to determine the inhibitory effect of intravenously administered C1-inhibitor as well as the influence of depletion of the human microbiota on allergic lung inflammation induced by house dust mite (HDM) plus…
To evaluate the efficacy of Cinryze administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free intravenous immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…