153 results
The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…
PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…
The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…
The primary objectives are:- To evaluate clinical remission for the 2 subcutaneous (SC) maintenance regimens of ustekinumab in subjects with moderately to severely active Crohn*s disease induced into clinical response with ustekinumab in the…
Aim of the studyTo study the effectiveness and toxicity of dexamethasone to prevent the occurrence of a pain flare after short schedule radiotherapy for painful bone metastases and to define the optimal schedule of dosing.Research questions:1. What…
Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…
Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.
The aim of this project is to evaluate the clinical value of biomarkers in adult patients with pulmonary hypertension, in particular:1) To quantify biomarkers of neurohormonal activity as NTproBNP, endotheline-1 and of immunological activity as CRP…
*To demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-CVP combination treatment to patients who receive MabThera®-CVP treatment. ORR will be determined during the combination treatment…
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…
To evaluate the effectiveness of bilateral implantation over unilateral implantation in children with severe-to-profound sensorineural hearing loss. Furthermore with this study we will investigate whether simultaneous bilateral implantation is…
The overall objective of this trial is to generate data on the ovarian stimulation profile obtained when Pergoveris® is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive). A…
The objective of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual…
- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…
1. To investigate the efficacy of Cogmed working memory training in reducing behavioral symptoms in children with neuropsychiatric disorders and borderline intellectual functioning.2. To investigate whether WM training improves neurocognitive…
Primary Objective: To evaluate the haemostatic effect of N9-GP during surgery procedures in patients with haemophilia B.Key Secondary Objectives• To evaluate the haemostatic effect of N9-GP during surgery and the postoperative period.• To evaluate…
This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of…
The primary objective of this study is to determine if there is an improvement in progression-free survival(PFS) when siltuximab is added to VELCADE* (bortezomib) and dexamethasone in subjects with relapsedor refractory multiple myeloma.The…