7 results
To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.
Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone(AAP) and AAP in subjects with chemotherapy-naïve mCRPC…
Primary objective:1. To evaluate the negative predictive value (NPV) of [68Ga]Ga-PentixaFor (PTF) PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS). Secondary objectives:2. To evaluate the…
Primary objectives-To assess the concordance between [68Ga]Ga-PentixaFor PET/CT and AVS for identification and/or lateralization of APAs in patients with PA. (Step 1) -To assess non-inferiority in terms of clinical outcomes of [68Ga]Ga-PentixaFor…
The aim of this study is to investigate the efficacy of subcutaneous IFX in the treatment of moderate to severe Crohn*s disease with and without concomitant immunosuppression, as measured by the proportion of patients in corticosteroid-free clinical…